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ClinicalTrialsDataProcessing
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youainti:history-download
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youainti:v1.0.0
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1
.dbeaver/.credentials-config.json.bak
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.dbeaver/.data-sources.json.bak
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{
"folders": {},
"connections": {
"mariaDB-186c896820e-6ff11b5b802d8b82": {
"provider": "mysql",
"driver": "mariaDB",
"name": "rxnav",
"save-password": true,
"configuration": {
"host": "will-office",
"port": "3306",
"url": "jdbc:mariadb://will-office:3306/",
"configurationType": "MANUAL",
"type": "dev",
"auth-model": "native"
}
},
"postgres-jdbc-186c896a347-2a3d946d2dea4df7": {
"provider": "postgresql",
"driver": "postgres-jdbc",
"name": "aact_db",
"save-password": true,
"configuration": {
"host": "will-office",
"port": "5432",
"database": "aact_db",
"url": "jdbc:postgresql://will-office:5432/aact_db",
"configurationType": "MANUAL",
"type": "dev",
"auth-model": "native"
}
}
},
"connection-types": {
"dev": {
"name": "Development",
"color": "255,255,255",
"description": "Regular development database",
"auto-commit": true,
"confirm-execute": false,
"confirm-data-change": false,
"auto-close-transactions": false
}
}
}

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.dbeaver/.project-metadata.json.bak
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{"resources":{"development_sql/ASSOICATING NCTIDs to NDCs and Marketing dates.sql":{"default-datasource":"postgres-jdbc-186c896a347-2a3d946d2dea4df7","default-catalog":"aact_db","default-schema":"public"}}}

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.gitattributes vendored
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*.sql.gzip filter=lfs diff=lfs merge=lfs -text
*.xlsx filter=lfs diff=lfs merge=lfs -text
containers/AACT_Reloader/2023-09-06_aactdb_with_matches.sql.gz filter=lfs diff=lfs merge=lfs -text
other_data/USP[[:space:]]DC/usp_dc_pub_2023_release_2.0_updated_final.csv filter=lfs diff=lfs merge=lfs -text
other_data/USP[[:space:]]MMG/MMG_v8.0_Alignment_File.csv filter=lfs diff=lfs merge=lfs -text
other_data/VA[[:space:]]Formulary/PharmacyProductSystem_NationalDrugCodeExtract.csv filter=lfs diff=lfs merge=lfs -text
containers/AACT_Reloader/backup/aact_db_backup_20250106_184236.sql.gz filter=lfs diff=lfs merge=lfs -text
containers/AACT_Reloader/backup/aact_db_backup_20250107_133822.sql.gz filter=lfs diff=lfs merge=lfs -text

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containers/drugcentral/docker-entrypoint-initdb.d/*.sql.gz containers/drugcentral/docker-entrypoint-initdb.d/*.sql.gz
containers/drugcentral/db_store/* containers/drugcentral/db_store/*
.dbeaver/

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Scripts/Backup_AACT_work.sh
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#!/bin/bash
backup_dir="/mnt/will/large_data/Research_large_data/ClinicalTrialsDataProcessing/containers/AACT_Reloader/backup/"
date_stamp=$(date +%Y%m%d_%H%M%S)
filename="aact_db_backup_${date_stamp}.sql"
container_name = ${1:-aact_db}
podman exec "$container_name" pg_dump -U root aact_db > "${backup_dir}/${filename}"
# Optional: compress the backup
gzip "${backup_dir}/${filename}"

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Scripts/ConfiguringFormularies.sql
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/*
I started by creating a formularies schema,
then importing the usp - dc formulary data through DBeaver's csv import.
*/
-- DROP SCHEMA "Formularies";
CREATE SCHEMA "Formularies" AUTHORIZATION root;
-- "Formularies".usp_dc_2023 definition
-- Drop table
-- DROP TABLE "Formularies".usp_dc_2023;
CREATE TABLE "Formularies".usp_dc_2023 (
rxcui varchar(15) NULL, --yes even though this is a number, it is represented as a string elsewhere.
tty varchar(10) NULL,
"Name" varchar(256) NULL,
"Related BN" varchar(250) NULL,
"Related DF" varchar(25050) NULL,
"USP Category" varchar(250) NULL,
"USP Class" varchar(250) NULL,
"USP Pharmacotherapeutic Group" varchar(250) NULL,
"API Concept" varchar(250) NULL
);
/*
I then linked the data back on itself with a materialized view, using claude.ai for simplicity.
Claude.ai > I need a postres sql statement to create a materialized view that will take the following table and link from a given rxcui to the other rxcui's that share the same category and class
```sql
CREATE TABLE "Formularies".usp_dc_2023 (
rxcui int4 NULL,
tty varchar(10) NULL,
"Name" varchar(256) NULL,
"Related BN" varchar(250) NULL,
"Related DF" varchar(25050) NULL,
"USP Category" varchar(250) NULL,
"USP Class" varchar(250) NULL,
"USP Pharmacotherapeutic Group" varchar(250) NULL,
"API Concept" varchar(250) NULL
);
```
It links rxcuis to other rxcuis where they have a matching USP Categories and Class
This gives alternative RXCUIs based on category an class.
*/
CREATE MATERIALIZED VIEW "Formularies".rxcui_category_class_links AS
WITH base AS (
SELECT DISTINCT
a.rxcui as source_rxcui,
b.rxcui as linked_rxcui,
a."USP Category" as category,
a."USP Class" as class
FROM "Formularies".usp_dc_2023 a
JOIN "Formularies".usp_dc_2023 b
ON a."USP Category" = b."USP Category"
AND a."USP Class" = b."USP Class"
AND a.rxcui != b.rxcui
WHERE a.rxcui IS NOT NULL
AND b.rxcui IS NOT NULL
)
SELECT * FROM base;
-- Add indexes for better query performance
CREATE INDEX ON "Formularies".rxcui_category_class_links (source_rxcui);
CREATE INDEX ON "Formularies".rxcui_category_class_links (linked_rxcui);
/*
Next step is linking a given nct -> compounds -> formulary alternatives -> compounds -> brands/generics.
I'll' break this into two steps.
1. link formulary alternatives to compounds and brands,
2. link nct_id to formulary alternatives
*/
drop if exists materialized view "Formularies".match_trial_compound_to_alternate_bn_rxcuis;
drop if exists materialized view "Formularies".rxcui_to_brand_through_uspdc cascade;
create materialized view "Formularies".rxcui_to_brand_through_uspdc AS
select distinct
rccl.source_rxcui
,rccl.linked_rxcui
,rccl.category
,rccl."class"
,rr.tty1
--,rr.tty2
,rr.rxcui2
from "Formularies".rxcui_category_class_links rccl
join rxnorm_migrated.rxnorm_relations rr on rr.rxcui1 = rccl.linked_rxcui
where rr.tty2 = 'BN'
;
/* So this one takes each RXCUI and it's associated RXCUIs from the same
category and class, and filters it down to associated RXCUI's that
represent brand names.
*/
create materialized view "Formularies".match_trial_compound_to_alternate_bn_rxcuis as
select distinct mttbi.nct_id, rtbtu.rxcui2 as brand_rxcuis
from match_trials_to_bn_in mttbi
join "Formularies".rxcui_to_brand_through_uspdc rtbtu
on mttbi.bn_or_in_cui = rtbtu.rxcui2
;
/*
This takes the list of ingredients and brands associated with a trial, and
links it to the list of alternative brand names.
*/
--renamed the view
CREATE OR REPLACE VIEW "Formularies".nct_to_brand_counts_through_uspdc
AS SELECT mtctabr.nct_id,
count(*) AS brand_name_counts
FROM "Formularies".match_trial_compound_to_alternate_bn_rxcuis mtctabr
GROUP BY mtctabr.nct_id;

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Scripts/Data_summaries.sql
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/* How many trials were included?
* How many trial were inspected?
* How many trials were reserved for downloaded?
* How many trials didn't get included for some technical reason?
*
********* Data from 2023-03-29 ***********
Of Interest 1981
Reserved 1709 #I believe this is lower than the downloaded number because I reserved them earlier
Downloaded 1960
Incomplete 3 #there were are few http 500 and 404 codes
******************************************
* Note there were 21 missing trials of interest.
* */
select status,count(distinct nct_id) from http.download_status ds
group by status;
/* Get a list of trials
* -- There are currently 304 trials for which I was able to extract unique snapshots (2023-03-29)
* -- There are currently 1138 trials for which I was able to extract unique snapshots (2023-04-03)
* */
select count(distinct nct_id) from history.trial_snapshots ts
/* Get the number of listed conditions
* -- There are only 609 listed (MeSH classified) conditions from 284 trials(2023-03-29)
* I may need to expand how I address conditions
*/
select count(*)
from ctgov.browse_conditions bc
where
mesh_type = 'mesh-list'
and
nct_id in (select distinct nct_id from history.trial_snapshots ts)
;
select count(distinct nct_id)
from ctgov.browse_conditions bc
where
mesh_type = 'mesh-list'
and
nct_id in (select distinct nct_id from history.trial_snapshots ts)
;
/*
* If I were to expand that to non-coded conditions that would be
* 304 trials with 398 conditions
* */
select count(distinct nct_id)
from ctgov.conditions bc
where
nct_id in (select distinct nct_id from history.trial_snapshots ts)
;
select count(*) from ctgov.conditions c
where
nct_id in (select distinct nct_id from history.trial_snapshots ts)
/* Get the number of matches from UMLS
* There are about 5,808 proposed matches.
*
*/
select count(*) from "DiseaseBurden".trial_to_icd10 tti ;
--1383 before run at 8pm 2023-03-29
--5209 at 2023-04-03T11:21
/*Get the number of trials that have links to icd10 trials*/
select tti.approved,count(distinct nct_id) from "DiseaseBurden".trial_to_icd10 tti
group by tti.approved;
-- finding and removing duplicates from the trial linking stuff. Useful when you redownload trials.
/*
with CTE as (
select row_number() over (partition by nct_id, "condition",ui) as rownum, *
from "DiseaseBurden".trial_to_icd10 tti
)
delete from "DiseaseBurden".trial_to_icd10 tti2
where id in (
select id from cte where rownum > 1
);
*/
--get the number of completed vs terminated trials
select overall_status,count(distinct nct_id)
from ctgov.studies s
where nct_id in (select distinct nct_id from "DiseaseBurden".trial_to_icd10 tti where tti.approved ='accepted' )
group by overall_status
;
select overall_status,count(distinct nct_id)
from ctgov.studies s
where nct_id in (select distinct nct_id from "DiseaseBurden".trial_to_icd10 tti)
group by overall_status
;
select overall_status,count(distinct nct_id)
from ctgov.studies s
where nct_id in (select distinct nct_id from history.trial_snapshots ts )
group by overall_status
;

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Scripts/DevelopingLinks.sql
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--TODO: Document and migrate to setup
drop table if exists "DiseaseBurden".trial_to_icd10;
drop type if exists "DiseaseBurden".validation_type;
create type "DiseaseBurden".validation_type as enum ('accepted', 'rejected', 'unmatched');
comment on type "DiseaseBurden".validation_type is 'This is used to record interactions with each type. It can be accepted (yes this should be used), rejected (no this doesn`t match), or unmatched (where non of the proposed options match)';
CREATE TABLE "DiseaseBurden".trial_to_icd10 (
id integer NOT NULL GENERATED ALWAYS AS IDENTITY,
nct_id varchar NOT NULL,
"condition" varchar NOT NULL,
ui varchar NULL,
uri varchar NULL,
rootsource varchar NULL,
"name" varchar NULL,
"source" varchar null,
approved "DiseaseBurden".validation_type,
approval_timestamp timestamp,
CONSTRAINT trial_to_icd10_pk PRIMARY KEY (id)
);
comment on type "DiseaseBurden".trial_to_icd10 is 'This represents potential links between trials and icd10 codes. Most of the links are both automatic and wrong.';
DROP TABLE if exists "DiseaseBurden".icd10_to_cause;
CREATE TABLE "DiseaseBurden".icd10_to_cause (
id SERIAL NOT NULL ,
code varchar NOT NULL,
cause_text varchar NOT NULL,
CONSTRAINT icd10_to_cause_pk PRIMARY KEY (id)
);

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Scripts/Extracting Tables Views and MatViews.sql
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SELECT
'CREATE OR REPLACE VIEW ' || schemaname || '.' || viewname || ' AS ' || definition
FROM pg_views
WHERE schemaname != 'pg_catalog'
and schemaname != 'information_schema' -- Replace with your schema name
;
SELECT
'CREATE OR REPLACE MATERIALIZED VIEW ' || schemaname || '.' || viewname || ' AS ' || definition
FROM pg_views
WHERE schemaname != 'pg_catalog'
and schemaname != 'information_schema'
;
SELECT
'CREATE TABLE ' || schemaname || '.' || tablename || E'\n(\n' ||
string_agg(column_definition, E',\n') || E'\n);\n'
FROM (
SELECT
schemaname,
tablename,
column_name || ' ' || data_type ||
CASE
WHEN character_maximum_length IS NOT NULL THEN '(' || character_maximum_length || ')'
ELSE ''
END ||
CASE
WHEN is_nullable = 'NO' THEN ' NOT NULL'
ELSE ''
END as column_definition
FROM pg_catalog.pg_tables t
JOIN information_schema.columns c
ON t.schemaname = c.table_schema
AND t.tablename = c.table_name
WHERE schemaname != 'pg_catalog'
and schemaname != 'information_schema'-- Replace with your schema name
) t
GROUP BY schemaname, tablename;

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Scripts/ExtractingData.sql
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create extension tablefunc;
/*Getting Trial Data all together
* There are 3 main datasets to join per trial:
*
* - Trial Data (still need to stick it together)
* - Duration and enrollment data
* - Compound Marketing (can get for any trial)
* - how many individual brands per compound at the start of the trial
* - Disease Data (can get for verified trials)
* - Population upper limit (Global Burdens of Disease)
* - Category (ICD10 2nd level groups)
*/
/*Disease Data*/
-- ICD10 Category and GBD data
with cte as (
select
nct_id,
max("level") as max_level
from trial_to_cause
group by nct_id
), cte2 as (
select
ttc.nct_id,
ttc.ui,
ttc."condition",
ttc.cause_text,
ttc.cause_id,
cte.max_level
from trial_to_cause ttc
join cte
on cte.nct_id=ttc.nct_id
where ttc."level"=cte.max_level
group by
ttc.nct_id,
ttc.ui,
ttc."condition",
ttc.cause_text,
ttc.cause_id,
cte.max_level
order by nct_id,ui
), cte3 as (
select
nct_id,
substring(cte2.ui for 3) as code,
cte2."condition",
cte2.cause_text,
cte2.cause_id,
ic.id as category_id,
ic.group_name
from cte2
join "DiseaseBurden".icd10_categories ic
on
substring(cte2.ui for 3) <= ic.end_code
and
substring(cte2.ui for 3) >= ic.start_code
)
select nct_id, cause_id,category_id
from cte3
group by nct_id, cause_id, category_id
;
--still need to link to actual disease burdens.
/*Compound Marketing Data*/
---Number of trials after a certain date
with marketing_cte as (
select nct_id,count(distinct application_number_or_citation)
from public.match_trial_to_marketing_start_date mttmsd
where "min" > '2012-06-01'
group by nct_id
)
select * from marketing_cte
;
/*Get versions*/
/* Ignore this version
with cte1 as (
select nct_id,min("version") over (partition by nct_id) as min_version
from history.trial_snapshots ts
where
ts.start_date < ts.submission_date
), cte2 as (
select * from cte1
group by nct_id, min_version
order by nct_id
), cte3 as (
select
ts2.nct_id,
ts2."version",
ts2.overall_status,
ts2.submission_date,
ts2.start_date,
ts2.enrollment,
ts2.enrollment_category,
ts2.primary_completion_date,
ts2.primary_completion_date_category ,
--mv.nct_id,
mv.min_version
from history.trial_snapshots ts2
join cte2 mv
on mv.nct_id = ts2.nct_id
where
ts2."version" = mv.min_version
order by ts2.nct_id
), cte4 as (
select cte3.nct_id, cte3.submission_date - cte3.start_date as submission_presecence
from cte3
)
select avg(submission_presecence)
from cte4
;
--avg 61 day difference
*/
--use this version
with cte1 as ( --get trials
select nct_id,max("version") over (partition by nct_id) as min_version
from history.trial_snapshots ts
where
ts.start_date > ts.submission_date
), cte2 as ( --
select * from cte1
group by nct_id, min_version
order by nct_id
), cte3 as (
select
ts2.nct_id,
ts2."version",
ts2.overall_status,
ts2.submission_date,
ts2.start_date,
ts2.enrollment,
ts2.enrollment_category,
ts2.primary_completion_date,
ts2.primary_completion_date_category ,
--mv.nct_id,
mv.min_version
from history.trial_snapshots ts2
join cte2 mv
on mv.nct_id = ts2.nct_id
where
ts2."version" = mv.min_version
order by ts2.nct_id
)
select *
from cte3
where
enrollment is null
or enrollment_category is null
or primary_completion_date is null
or primary_completion_date_category is null
or start_date is null
/*, cte4 as (
select cte3.nct_id, cte3.submission_date - cte3.start_date as submission_presecence
from cte3
)
select avg(submission_presecence)
from cte4
; -- -33 day difference on average
*/
with cte1_min as (
select nct_id,min("version") over (partition by nct_id) as min_version
from history.trial_snapshots ts
where
ts.start_date <= ts.submission_date
),cte1_max as (
select nct_id,max("version") over (partition by nct_id) as max_version
from history.trial_snapshots ts
where
ts.start_date >= ts.submission_date
), cte2_min as (
select * from cte1_min
group by nct_id, min_version
), cte2_max as (
select * from cte1_max
group by nct_id, max_version
)
select *
from cte2_min
join cte2_max
on cte2_min.nct_id=cte2_max.nct_id
where min_version >= max_version
/* Neet to take a different tack in filling out the is version of the data.
* The idea is that we need the latest of each major category
* before the start date.
* */
--get the set of trials which have
with cte as (
/* Get the absolute difference between the start date and the
* submission_date for each version of the trial (measured in days)
*
*/
select
s.nct_id,
s.start_date,
ts."version",
ts.submission_date,
abs(extract(epoch from ts.submission_date - s.start_date)::float/(24*60*60)) as start_deviance
from ctgov.studies s
join history.trial_snapshots ts
on s.nct_id = ts.nct_id
where s.nct_id in (select distinct nct_id from "DiseaseBurden".trial_to_icd10 tti)
),cte2 as (
/* Rank each version based on it's proximity to the start date
* */
select
cte.nct_id,
cte."version",
row_number() over (partition by cte.nct_id order by cte.start_deviance) as rownum,
cte.submission_date,
cte.start_deviance,
cte.start_date,
ts.primary_completion_date ,
ts.primary_completion_date_category ,
ts.overall_status ,
ts.enrollment ,
ts.enrollment_category
from cte
join history.trial_snapshots ts
on cte.nct_id=ts.nct_id and cte."version"=ts."version"
), cte3_primary_completion as (
/* for each trial
* select the version with a filled out primary_completion_source
* that is closest to the start date.
* */
select cte2.nct_id, min(cte2.rownum) as primary_completion_source
from cte2
where cte2.primary_completion_date is not null
group by cte2.nct_id
), cte3_enrollment as (
/* for each trial
* select the version with a filled out enrollment
* that is closest to the start date.
* */
select cte2.nct_id, min(cte2.rownum) as enrollment_source
from cte2
where cte2.enrollment is not null
group by cte2.nct_id
), cte4 as (
/* join the best options together to get the data of interest.
*
* On further inspection there are just a view of those, with
* many of them having a 7+ month difference between the two versions.
* I think I am going to drop them.
* */
select
c3e.nct_id,
--c2a.submission_date as submission_date_a,
--c2b.submission_date as submission_date_b,
--c3e.enrollment_source,
c2a."version" as version_a,
c2a.enrollment,
c2a.enrollment_category,
--c3p.primary_completion_source ,
c2b."version" as version_b,
c2b.primary_completion_date,
c2b.primary_completion_date_category
from cte3_enrollment c3e
join cte2 c2a
on c3e.nct_id = c2a.nct_id and c3e.enrollment_source = c2a.rownum
join cte3_primary_completion c3p
on c3e.nct_id = c3p.nct_id
join cte2 c2b
on c3p.nct_id=c2b.nct_id and c3p.primary_completion_source = c2b.rownum
), cte5 as (
select nct_id
from cte4 where version_a != version_b
)
select
c.nct_id,
s2.overall_status,
c.enrollment as planned_enrollment,
s2.enrollment,
s2.start_date,
c.primary_completion_date as planned_primary_completion_date,
s2.primary_completion_date,
extract(epoch from c.primary_completion_date - s2.start_date)/(24*60*60) as planned_duration,
s2.primary_completion_date - s2.start_date as actual_duration
from cte4 c
join ctgov.studies s2
on c.nct_id = s2.nct_id
where c.nct_id not in (select nct_id from cte5)
;
/*
* Concern about causal inference
*
* When putting the data together for CBO it looked like we got occasional updates about
* the status of trials that included enrollment updates.
* That doesn't appear to be the case, but that messes with the ability to causally identify
* any results. I need to be careful about this data is used.
*
* I created the statements below to get the data that I need.
*/
----get the set of trial snapshots
create or replace view public.view_cte as
select
nct_id,
primary_completion_date,
primary_completion_date_category,
enrollment,
start_date,
enrollment_category ,
overall_status,
--count("version"),
min(submission_date) as earliest_date_observed
from history.trial_snapshots ts
where
nct_id in (select distinct nct_id from "DiseaseBurden".trial_to_icd10 tti where tti.approved='accepted')
and submission_date >= start_date
and overall_status not in ('Completed','Terminated')
group by
nct_id,
primary_completion_date,
primary_completion_date_category,
start_date,
enrollment,
enrollment_category ,
overall_status
;
create or replace view public.view_disbur_cte0 as
select tti.nct_id, tti.ui , tti."condition",itc.cause_text, ch.cause_id, ch."level"
from "DiseaseBurden".trial_to_icd10 tti
join "DiseaseBurden".icd10_to_cause itc
on replace(REPLACE(tti.ui,'-',''),'.','') = replace(REPLACE(itc.code ,'-',''),'.','')
join "DiseaseBurden".cause_hierarchy ch
on itc.cause_text = ch.cause_name
where
tti.approved = 'accepted'
;
create or replace view public.view_trial_to_cause as
select tti.nct_id, tti.ui , tti."condition",itc.cause_text, ch.cause_id, ch."level"
from "DiseaseBurden".trial_to_icd10 tti
join "DiseaseBurden".icd10_to_cause itc
on replace(REPLACE(tti.ui,'-',''),'.','') = replace(REPLACE(itc.code ,'-',''),'.','')
join "DiseaseBurden".cause_hierarchy ch
on itc.cause_text = ch.cause_name
where
tti.approved = 'accepted'
order by nct_id
;--does this duplicate the view above?
create or replace view public.view_disbur_cte as
select
nct_id,
max("level") as max_level
from view_disbur_cte0
group by nct_id
;
create or replace view public.view_disbur_cte2 as
select
ttc.nct_id,
ttc.ui,
ttc."condition",
ttc.cause_text,
ttc.cause_id,
disbur_cte.max_level
from view_trial_to_cause ttc
join view_disbur_cte as disbur_cte
on disbur_cte.nct_id=ttc.nct_id
where ttc."level"=disbur_cte.max_level
group by
ttc.nct_id,
ttc.ui,
ttc."condition",
ttc.cause_text,
ttc.cause_id,
disbur_cte.max_level
order by nct_id,ui
;
create or replace view public.view_disbur_cte3 as
select
nct_id,
substring(disbur_cte2.ui for 3) as code,
disbur_cte2."condition",
disbur_cte2.cause_text,
disbur_cte2.cause_id,
ic.chapter_code as category_id,
ic.group_name,
disbur_cte2.max_level
from view_disbur_cte2 as disbur_cte2
join "DiseaseBurden".icd10_categories ic
on
substring(disbur_cte2.ui for 3) <= ic.end_code
and
substring(disbur_cte2.ui for 3) >= ic.start_code
where ic."level" = 1
;
create or replace view public.view_burdens_cte as
select *
from "DiseaseBurden".burdens b
where b.sex_id = 3 --both sexes
and b.metric_id = 1 --number/count
and b.measure_id = 2 --DALYs
and b.age_id =22 --all ages
;
create or replace view public.view_burdens_cte2 as
select
--c1.location_id,
c1.cause_id,
c1."year",
--high sdi
c1.val as h_sdi_val,
c1.upper_95 as h_sdi_u95,
c1.lower_95 as h_sdi_l95,
--high-middle sdi
c2.val as hm_sdi_val,
c2.upper_95 as hm_sdi_u95,
c2.lower_95 as hm_sdi_l95,
--middle sdi
c3.val as m_sdi_val,
c3.upper_95 as m_sdi_u95,
c3.lower_95 as m_sdi_l95,
--low-middle sdi
c4.val as lm_sdi_val,
c4.upper_95 as lm_sdi_u95,
c4.lower_95 as lm_sdi_l95,
--low sdi
c5.val as l_sdi_val,
c5.upper_95 as l_sdi_u95,
c5.lower_95 as l_sdi_l95
from view_burdens_cte c1
join view_burdens_cte c2
on c1.cause_id = c2.cause_id
and c1."year" = c2."year"
join view_burdens_cte c3
on c1.cause_id = c3.cause_id
and c1."year" = c3."year"
join view_burdens_cte c4
on c1.cause_id = c4.cause_id
and c1."year" = c4."year"
join view_burdens_cte c5
on c1.cause_id = c5.cause_id
and c1."year" = c5."year"
where c1.location_id = 44635
and c2.location_id = 44634
and c3.location_id = 44639
and c4.location_id = 44636
and c5.location_id = 44637
;
--drop view if exists public.formatted_data cascade;
create or replace view public.formatted_data as
select
cte.nct_id,
cte.start_date,
cte.enrollment as current_enrollment,
cte.enrollment_category,
cte.overall_status as current_status,
cte.earliest_date_observed,
extract( epoch from (cte.earliest_date_observed - cte.start_date))/extract( epoch from (cte.primary_completion_date - cte.start_date)) as elapsed_duration
,count(distinct mttmsd."application_number_or_citation") as n_brands
,dbc3.code
,dbc3."condition"
,dbc3.cause_text
,dbc3.cause_id
,dbc3.category_id
,dbc3.group_name
,dbc3.max_level
--c1.location_id,
--,b.cause_id
,b."year",
--high sdi
b.h_sdi_val,
b.h_sdi_u95,
b.h_sdi_l95,
--high-middle sdi
b.hm_sdi_val,
b.hm_sdi_u95,
b.hm_sdi_l95,
--middle sdi
b.m_sdi_val,
b.m_sdi_u95,
b.m_sdi_l95,
--low-middle sdi
b.lm_sdi_val,
b.lm_sdi_u95,
b.lm_sdi_l95,
--low sdi
b.l_sdi_val,
b.l_sdi_u95,
b.l_sdi_l95
from view_cte as cte
join public.match_trial_to_marketing_start_date mttmsd
on cte.nct_id = mttmsd."nct_id"
join view_disbur_cte3 dbc3
on dbc3.nct_id = cte.nct_id
join view_burdens_cte2 b
on b.cause_id = dbc3.cause_id and extract(year from b."year") = extract(year from cte.earliest_date_observed)
where
mttmsd."min" <= cte.earliest_date_observed
group by
cte.nct_id,
cte.start_date,
cte.enrollment,
cte.enrollment_category,
cte.overall_status,
cte.earliest_date_observed,
elapsed_duration
,dbc3.code
,dbc3."condition"
,dbc3.cause_text
,dbc3.cause_id
,dbc3.category_id
,dbc3.group_name
,dbc3.max_level
--c1.location_id,
,b.cause_id,
b."year",
--high sdi
b.h_sdi_val,
b.h_sdi_u95,
b.h_sdi_l95,
--high-middle sdi
b.hm_sdi_val,
b.hm_sdi_u95,
b.hm_sdi_l95,
--middle sdi
b.m_sdi_val,
b.m_sdi_u95,
b.m_sdi_l95,
--low-middle sdi
b.lm_sdi_val,
b.lm_sdi_u95,
b.lm_sdi_l95,
--low sdi
b.l_sdi_val,
b.l_sdi_u95,
b.l_sdi_l95
order by cte.nct_id ,cte.earliest_date_observed
;--used this one 2023-04-05
--get the planned enrollment
create or replace view public.time_between_submission_and_start_view as
/* Get the absolute difference between the start date and the
* submission_date for each version of the trial (measured in days)
*
*/
select
s.nct_id,
s.start_date,
ts."version",
ts.submission_date,
abs(extract(epoch from ts.submission_date - s.start_date)::float/(24*60*60)) as start_deviance
from ctgov.studies s
join history.trial_snapshots ts
on s.nct_id = ts.nct_id
where s.nct_id in (select distinct nct_id from "DiseaseBurden".trial_to_icd10 tti)
;
create or replace view rank_proximity_to_start_time_view as
/* Rank each version based on it's proximity to the start date
* */
select
cte.nct_id,
cte."version",
row_number() over (partition by cte.nct_id order by cte.start_deviance) as rownum,
cte.submission_date,
cte.start_deviance,
cte.start_date,
ts.primary_completion_date ,
ts.primary_completion_date_category ,
ts.overall_status ,
ts.enrollment ,
ts.enrollment_category
from public.time_between_submission_and_start_view cte
join history.trial_snapshots ts
on cte.nct_id=ts.nct_id and cte."version"=ts."version"
;
create or replace view enrollment_closest_to_start_view as
/* for each trial
* select the version with a filled out enrollment
* that is closest to the start date.
* */
select cte2.nct_id, min(cte2.rownum) as enrollment_source
from rank_proximity_to_start_time_view cte2
where cte2.enrollment is not null
group by cte2.nct_id
;
--drop view public.formatted_data_with_planned_enrollment ;
create or replace view formatted_data_with_planned_enrollment as
select
f.*,
s.overall_status as final_status,
c2a."version",
c2a.enrollment as planned_enrollment
from formatted_data f
join ctgov.studies s
on f.nct_id = s.nct_id
join enrollment_closest_to_start_view c3e
on c3e.nct_id = f.nct_id
join rank_proximity_to_start_time_view c2a
on c3e.nct_id = c2a.nct_id and c3e.enrollment_source = c2a.rownum
;
select * from formatted_data_with_planned_enrollment
-------------------GET COUNTS------------------
select count(distinct nct_id) from public.view_cte; --88
select count(distinct nct_id) from public.view_disbur_cte0; --130
select count(distinct nct_id) from public.view_trial_to_cause; --130
select count(distinct nct_id) from public.view_disbur_cte;--130
select count(distinct nct_id) from public.view_disbur_cte2;--130
select count(distinct nct_id) from public.view_disbur_cte3;--130
select count(distinct nct_id) from public.formatted_data; --48 probably because there are so many trials that don't fall into a GBD category/cause
select count(distinct nct_id) from public.time_between_submission_and_start_view;--1067
select count(distinct nct_id) from rank_proximity_to_start_time_view;--1067
select count(distinct nct_id) from enrollment_closest_to_start_view;--1067
select count(distinct nct_id) from formatted_data_with_planned_enrollment;--48
select count(distinct nct_id) from public.view_trial_to_cause; --130
select count(distinct nct_id) from formatted_data_with_planned_enrollment;--48
--get durations and count snapshots per trial per trial
with cte1 as (
select
nct_id,
start_date ,
primary_completion_date,
overall_status ,
primary_completion_date - start_date as duration
from ctgov.studies s
where nct_id in (select distinct nct_id from http.download_status ds)
), cte2 as (
select nct_id,count(*) as snapshot_count from formatted_data_with_planned_enrollment fdwpe
group by nct_id
)
select a.nct_id, a.overall_status, a.duration,b.snapshot_count
from cte1 as a
join cte2 as b
on a.nct_id=b.nct_id
;

104
Scripts/GroupingTrials.sql
Unescape Escape View File

@ -1,104 +0,0 @@
select * from "DiseaseBurden".icd10_to_cause itc ;
select * from "DiseaseBurden".cause c ;
select c.id, count(distinct code)
from "DiseaseBurden".cause c
join "DiseaseBurden".icd10_to_cause itc
on c.cause = itc.cause_text
group by c.id
order by c.id
;
select tti.approved,count(distinct nct_id) from "DiseaseBurden".trial_to_icd10 tti
group by tti.approved;
select nct_id, "condition", ui
from "DiseaseBurden".trial_to_icd10 tti
where tti.approved = 'accepted';
drop view trial_to_cause;
---Link trials to their causes
create temp view trial_to_cause as
select tti.nct_id, tti.ui , tti."condition",itc.cause_text, ch.cause_id, ch."level"
from "DiseaseBurden".trial_to_icd10 tti
join "DiseaseBurden".icd10_to_cause itc
on replace(REPLACE(tti.ui,'-',''),'.','') = replace(REPLACE(itc.code ,'-',''),'.','')
join "DiseaseBurden".cause_hierarchy ch
on itc.cause_text = ch.cause_name
where
tti.approved = 'accepted'
order by nct_id
;
select distinct nct_id, count(*), min("level"), max("level")
from trial_to_cause ttc
group by nct_id
;
select nct_id,cause_text,cause_id from trial_to_cause
where level = 3
group by nct_id,cause_text,cause_id
order by cause_id
;
select cause_id,"condition",cause_text,count(distinct nct_id) as c
from trial_to_cause
where level >= 3
group by cause_id,"condition",cause_text
--having count(distinct nct_id) > 2
order by cause_id
;
with cte as (
select
nct_id,
max("level") as max_level
from trial_to_cause
group by nct_id
), cte2 as (
select
ttc.nct_id,
ttc.ui,
ttc."condition",
ttc.cause_text,
ttc.cause_id,
cte.max_level
from trial_to_cause ttc
join cte
on cte.nct_id=ttc.nct_id
where ttc."level"=cte.max_level
group by
ttc.nct_id,
ttc.ui,
ttc."condition",
ttc.cause_text,
ttc.cause_id,
cte.max_level
order by nct_id,ui
), cte3 as (
select
nct_id,
substring(cte2.ui for 3) as code,
cte2."condition",
cte2.cause_text,
cte2.cause_id,
ic.id as category_id,
ic.group_name
from cte2
join "DiseaseBurden".icd10_categories ic
on
substring(cte2.ui for 3) <= ic.end_code
and
substring(cte2.ui for 3) >= ic.start_code
)
select nct_id, cause_id,category_id
from cte3
group by nct_id, cause_id, category_id
;

83
Scripts/TablesAndViews_Public.sql
Unescape Escape View File

@ -1,83 +0,0 @@
drop view if exists public.match_trial_to_marketing_start_date;
DROP VIEW if exists public.match_trial_to_ndc11;
drop view if exists public.match_trials_to_bn_in;
drop view if exists history.match_drugs_to_trials;
DROP TABLE IF EXISTS history.trial_snapshots;
CREATE TABLE IF NOT EXISTS history.trial_snapshots
(
nct_id character varying(15) COLLATE pg_catalog."default" NOT NULL,
version integer NOT NULL,
submission_date timestamp without time zone,
primary_completion_date timestamp without time zone,
primary_completion_date_category history.updatable_catetories,
start_date timestamp without time zone,
start_date_category history.updatable_catetories,
completion_date timestamp without time zone,
completion_date_category history.updatable_catetories,
overall_status history.study_statuses,
enrollment integer,
enrollment_category history.updatable_catetories,
sponsor character varying COLLATE pg_catalog."default",
responsible_party character varying COLLATE pg_catalog."default",
CONSTRAINT trial_snapshots_pkey PRIMARY KEY (nct_id, version)
);
ALTER TABLE IF EXISTS history.trial_snapshots
OWNER to root;
CREATE OR REPLACE VIEW history.match_drugs_to_trials
AS SELECT bi.nct_id,
rp.rxcui,
rp.propvalue1
FROM ctgov.browse_interventions bi
JOIN rxnorm_migrated.rxnorm_props rp ON bi.downcase_mesh_term::text = rp.propvalue1::text
WHERE rp.propname::text = 'RxNorm Name'::text AND (bi.nct_id::text IN ( SELECT trial_snapshots.nct_id
FROM history.trial_snapshots));
CREATE OR REPLACE VIEW public.match_trials_to_bn_in
AS WITH trialncts AS (
SELECT DISTINCT ts.nct_id
FROM history.trial_snapshots ts
)
SELECT bi.nct_id,
bi.downcase_mesh_term,
rr.tty2,
rr.rxcui2 AS bn_or_in_cui,
count(*) AS count
FROM ctgov.browse_interventions bi
LEFT JOIN rxnorm_migrated.rxnorm_props rp ON bi.downcase_mesh_term::text = rp.propvalue1::text
LEFT JOIN rxnorm_migrated.rxnorm_relations rr ON rr.rxcui1 = rp.rxcui
WHERE (bi.nct_id::text IN ( SELECT trialncts.nct_id
FROM trialncts)) AND bi.mesh_type::text = 'mesh-list'::text AND rp.propname::text = 'Active_ingredient_name'::text AND (rr.tty2 = ANY (ARRAY['BN'::bpchar, 'IN'::bpchar, 'MIN'::bpchar]))
GROUP BY bi.nct_id, bi.downcase_mesh_term, rr.tty2, rr.rxcui2
ORDER BY bi.nct_id;
CREATE OR REPLACE VIEW public.match_trial_to_ndc11
AS SELECT mttbi.nct_id,
ah.ndc,
count(*) AS count
FROM match_trials_to_bn_in mttbi
LEFT JOIN rxnorm_migrated.rxnorm_relations rr ON mttbi.bn_or_in_cui = rr.rxcui1
LEFT JOIN rxnorm_migrated."ALLNDC_HISTORY" ah ON rr.rxcui2 = ah.rxcui
WHERE rr.tty1 = 'BN'::bpchar AND (rr.tty2 = ANY (ARRAY['SBD'::bpchar, 'BPCK'::bpchar])) AND ah.sab::text = 'RXNORM'::text
GROUP BY mttbi.nct_id, ah.ndc
ORDER BY mttbi.nct_id, ah.ndc;
CREATE OR REPLACE VIEW public.match_trial_to_marketing_start_date
AS SELECT mttn.nct_id,
n.application_number_or_citation,
min(n.marketing_start_date) AS min
FROM match_trial_to_ndc11 mttn
JOIN spl.nsde n ON mttn.ndc = n.package_ndc11::bpchar
WHERE n.product_type::text = 'HUMAN PRESCRIPTION DRUG'::text AND (n.marketing_category::text = ANY (ARRAY['NDA'::character varying, 'ANDA'::character varying, 'BLA'::character varying, 'NDA authorized generic'::character varying, 'NDA AUTHORIZED GENERIC'::character varying]::text[]))
GROUP BY mttn.nct_id, n.application_number_or_citation
ORDER BY mttn.nct_id;

308
Scripts/VariousDevelopmentsForAnalysis.sql
Unescape Escape View File

@ -1,308 +0,0 @@
select * from formatted_data_with_planned_enrollment fdwpe
;
select * from formatted_data_mat fdm
;
select count(distinct condition ) from formatted_data_mat fdm
select nct_id, fdm.current_status , count(*)
from formatted_data_mat fdm
group by nct_id , fdm.current_status
order by nct_id
;
select * from formatted_data_mat fdm ;
-- group with trial split
with cte as (
select nct_id
from formatted_data_mat fdm
group by nct_id
having count(distinct current_status) > 1
order by nct_id
)
select
fdm.nct_id
, current_status
, earliest_date_observed
, elapsed_duration
, n_brands
, category_id
, h_sdi_val
, h_sdi_u95
, h_sdi_l95
, hm_sdi_val
, hm_sdi_u95
, hm_sdi_l95
, m_sdi_val
, m_sdi_u95
, m_sdi_l95
, lm_sdi_val
, lm_sdi_u95
, lm_sdi_l95
, l_sdi_val
, l_sdi_u95
, l_sdi_l95
from formatted_data_mat fdm
join cte on cte.nct_id = fdm.nct_id
group by
fdm.nct_id
, current_status
, earliest_date_observed
, elapsed_duration
, n_brands
, category_id
, h_sdi_val
, h_sdi_u95
, h_sdi_l95
, hm_sdi_val
, hm_sdi_u95
, hm_sdi_l95
, m_sdi_val
, m_sdi_u95
, m_sdi_l95
, lm_sdi_val
, lm_sdi_u95
, lm_sdi_l95
, l_sdi_val
, l_sdi_u95
, l_sdi_l95
order by nct_id , earliest_date_observed
;
select count(distinct category_id ) from
select distinct category_id from formatted_data_mat fdm
;
-- group with trial split
with cte as (
select nct_id
from formatted_data_mat fdm
group by nct_id
having count(distinct current_status) > 1
order by nct_id
)
select
fdm.nct_id
, current_status
, earliest_date_observed
, elapsed_duration
, n_brands
, category_id
, h_sdi_val
, h_sdi_u95
, h_sdi_l95
, hm_sdi_val
, hm_sdi_u95
, hm_sdi_l95
, m_sdi_val
, m_sdi_u95
, m_sdi_l95
, lm_sdi_val
, lm_sdi_u95
, lm_sdi_l95
, l_sdi_val
, l_sdi_u95
, l_sdi_l95
from formatted_data_mat fdm
join cte on cte.nct_id = fdm.nct_id
group by
fdm.nct_id
, current_status
, earliest_date_observed
, elapsed_duration
, n_brands
, category_id
, h_sdi_val
, h_sdi_u95
, h_sdi_l95
, hm_sdi_val
, hm_sdi_u95
, hm_sdi_l95
, m_sdi_val
, m_sdi_u95
, m_sdi_l95
, lm_sdi_val
, lm_sdi_u95
, lm_sdi_l95
, l_sdi_val
, l_sdi_u95
, l_sdi_l95
order by nct_id , earliest_date_observed
; --TODO: join to usp dc dataset
WITH trialncts AS (
SELECT DISTINCT ts.nct_id
FROM history.trial_snapshots ts
), nct_to_cui AS (
SELECT bi.nct_id,
bi.downcase_mesh_term,
rr.tty2,
rr.rxcui2 AS approved_drug_rxcui,
count(*) AS count
FROM ctgov.browse_interventions bi
LEFT JOIN rxnorm_migrated.rxnorm_props rp ON bi.downcase_mesh_term::text = rp.propvalue1::text
LEFT JOIN rxnorm_migrated.rxnorm_relations rr ON rr.rxcui1 = rp.rxcui
WHERE (bi.nct_id::text IN ( SELECT trialncts.nct_id
FROM trialncts)) AND bi.mesh_type::text = 'mesh-list'::text AND rp.propname::text = 'Active_ingredient_name'::text AND (rr.tty2::text = ANY (ARRAY['BPCK'::text, 'SCD'::text, 'SBD'::text, 'GPCK'::text]))
GROUP BY bi.nct_id, bi.downcase_mesh_term, rr.tty2, rr.rxcui2
)
SELECT nct_to_cui.nct_id,
ud."USP Category",
ud."USP Class"
FROM nct_to_cui
JOIN "Formularies".usp_dc ud ON ud.rxcui::bpchar = nct_to_cui.approved_drug_rxcui
GROUP BY nct_to_cui.nct_id, ud."USP Category", ud."USP Class"
ORDER BY nct_to_cui.nct_id;
CREATE MATERIALIZED VIEW "Formularies".nct_to_brands_through_uspdc
AS
WITH trialncts AS (
SELECT DISTINCT ts.nct_id
FROM history.trial_snapshots ts
)
SELECT
bi.nct_id,
count( distinct rr2.rxcui2 ) as brand_name_count
FROM ctgov.browse_interventions bi
LEFT JOIN rxnorm_migrated.rxnorm_props rp ON bi.downcase_mesh_term::text = rp.propvalue1::text --match mesh terms to rxcui
LEFT JOIN rxnorm_migrated.rxnorm_relations rr ON rr.rxcui1 = rp.rxcui -- match rxcui to relations between rxcuis
LEFT JOIN rxnorm_migrated.rxnorm_relations rr2 ON rr.rxcui2 = rr2.rxcui1 -- match rxcui to relations between rxcuis
WHERE
(bi.nct_id::text IN (SELECT trialncts.nct_id FROM trialncts)) --check the nct_id is in our list
AND
bi.mesh_type::text = 'mesh-list'::text --we are only looking at mesh "list" rxcuis
AND rp.propname::text = 'Active_ingredient_name'::text --and we only care about active ingredients linked to \/\/\/\/\/
AND (rr.tty2::text = ANY (ARRAY['BPCK'::text, 'SCD'::text, 'SBD'::text, 'GPCK'::text])) --and we are linking from active ingredients ^^^^ to branded packs
AND (rr2.tty2::text = 'BN') --and from branded packs back to brand names
GROUP BY bi.nct_id --remove duplicates
;
/*
*
*/
select
fdqpe.nct_id
--,fdqpe.start_date
--,fdqpe.current_enrollment
--,fdqpe.enrollment_category
,fdqpe.current_status
,fdqpe.earliest_date_observed
,fdqpe.elapsed_duration
,fdqpe.n_brands as identical_brands
,ntbtu.brand_name_count
,fdqpe.category_id
,fdqpe.final_status
,fdqpe.h_sdi_val
--,fdqpe.h_sdi_u95
--,fdqpe.h_sdi_l95
,fdqpe.hm_sdi_val
--,fdqpe.hm_sdi_u95
--,fdqpe.hm_sdi_l95
,fdqpe.m_sdi_val
--,fdqpe.m_sdi_u95
--,fdqpe.m_sdi_l95
,fdqpe.lm_sdi_val
--,fdqpe.lm_sdi_u95
--,fdqpe.lm_sdi_l95
,fdqpe.l_sdi_val
--,fdqpe.l_sdi_u95
--,fdqpe.l_sdi_l95
from formatted_data_mat fdqpe
join "Formularies".nct_to_brands_through_uspdc ntbtu
on fdqpe.nct_id = ntbtu.nct_id
;
--example of multiple reopenings
select *
from formatted_data_mat fdm
where nct_id = 'NCT01239797'
--attempt to automatically find transition periods
with cte1 as (
select nct_id, min(earliest_date_observed) over (partition by nct_id) as earliest_closed_enrollment
from formatted_data_mat fdm
where current_status = 'Active, not recruiting'
), cte2 as (
select nct_id, max(earliest_date_observed) over (partition by nct_id) latest_open_enrollment
from formatted_data_mat fdm
where current_status != 'Active, not recruiting'
)
select
cte1.nct_id
,cte1.earliest_closed_enrollment
,cte2.latest_open_enrollment
,cte1.earliest_closed_enrollment - cte2.latest_open_enrollment
from cte1
join cte2 on cte1.nct_id = cte2.nct_id
/*group by
cte1.nct_id
,cte1.earliest_closed_enrollment
,cte2.latest_open_enrollment
*/
/* So ocassionally a study reopens enrollment.
* If that didn't happen, then I could just find the first enrollment matching X and/or last enrollment matching Y
* to get the transitions
* Instead I need to create shifts of statuses between snapshots, and then remove all of those that did not change.
*
* Better yet, just get the last shift to ANR.
* */
/* Take each entry and get the status from a lagged snapshot
* Then select each snapshot moving from previous_state to ANR
* and filter out everything except the last one.
* */
with cte as (
select
nct_id
,lag(current_status, 1) over (partition by nct_id order by earliest_date_observed) as previous_status
,current_status
,earliest_date_observed as date_current
from formatted_data_mat fdm
), cte2 as (
select
nct_id
,previous_status
,current_status
,max(date_current) as date_current_max
from cte
where
previous_status != current_status
and
current_status = 'Active, not recruiting'
group by
nct_id
,previous_status
,current_status
,date_current
)
select *
from formatted_data_mat fdm
join cte2
on cte2.nct_id = fdm.nct_id
and cte2.date_current_max = fdm.earliest_date_observed
; --join back into

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Scripts/export_tables.sh
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#!/bin/bash
set -x
# Uses
#
# Defauls
if [[ $# -lt 1 ]]; then
echo "Usage: pg_export container_name [database_name] [username]"
return 1
fi
CONTAINER=$1
DBNAME=${2:-aact_db}
USER=${3:-root}
#
# for sqlfile in ../export/export_data_*.sql; do
# if [[ -f "$sqlfile" ]]; then
# outfile="../export/output_$(date -I)_$(basename ${sqlfile%.sql}).sql"
# # podman exec -t "$CONTAINER" psql -U "$USER" -d "$DBNAME" -t -A -f - < "$sqlfile" > "$outfile"
# # podman exec "$CONTAINER" psql -U "$USER" -d "$DBNAME" -t -A -f "$sqlfile" > "$outfile"
# podman cp "$sqlfile" "$CONTAINER":/tmp/query.sql
# podman exec "$CONTAINER" psql -U "$USER" -d "$DBNAME" -t -A -f /tmp/query.sql > "$outfile"
# fi
# done
#
for sqlfile in ../export/export_data_*.sql; do
if [[ -f "$sqlfile" ]]; then
outfile="../export/output_$(date -I)_$(basename ${sqlfile%.sql}).sql"
podman cp "$sqlfile" "$CONTAINER":/tmp/query.sql
podman exec "$CONTAINER" psql -U "$USER" -d "$DBNAME" -f "/tmp/query.sql" > "$outfile"
fi
done

3
TODO.md
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# TODO
Code up a data extraction tool that uses llama3 or a similar quality source to extract the data that I need from the extended aact_database

1
containers/AACT_Reloader/.gitattributes vendored
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backup/2023-09-06_aactdb_with_matches.sql.gz filter=lfs diff=lfs merge=lfs -text

42
containers/AACT_Reloader/StartRestoreContainer.sh
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#!/bin/bash
RESTORE_DUMP_GZ="${1:-aact_db_backup_20250107_133822.sql.gz}"
POSTGRES_USER=root
POSTGRES_PASSWORD=root
POSTGRES_DB=aact_db
CONTAINER_NAME="${POSTGRES_DB}-restored-$(date -I)"
#start container
podman run \
-e POSTGRES_PASSWORD="${POSTGRES_PASSWORD}" \
-e POSTGRES_USER="${POSTGRES_USER}" \
-e POSTGRES_DB="${POSTGRES_DB}" \
--name "${CONTAINER_NAME}" \
--detach \
--network research-network \
--shm-size=512mb \
--volume ./backup/:/backup/ \
-p 5432:5432\
postgres:14-alpine
sleep 10
# Function to check if PostgreSQL is ready
function check_postgres {
podman exec -i "${CONTAINER_NAME}" psql -h localhost -U "${POSTGRES_USER}" -d "${POSTGRES_DB}" -c '\q' > /dev/null 2>&1
}
# Wait for PostgreSQL to be ready
until check_postgres; do
echo "Waiting for PostgreSQL to be ready..."
sleep 4
done
echo "PostgreSQL is ready. Restoring the database..."
# Decompress the dump file and restore it to the database
podman exec -i "${CONTAINER_NAME}" sh -c "gunzip -c /backup/${RESTORE_DUMP_GZ} | psql -h localhost -U ${POSTGRES_USER} -d ${POSTGRES_DB}"
echo "Database restoration complete."

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containers/AACT_downloader/docker-entrypoint-initdb.d/030_HistoricalSchema.sql
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@ -97,7 +97,6 @@ CREATE TABLE IF NOT EXISTS history.trial_snapshots
( (
nct_id character varying(15) COLLATE pg_catalog."default" NOT NULL, nct_id character varying(15) COLLATE pg_catalog."default" NOT NULL,
version integer NOT NULL, version integer NOT NULL,
submission_date timestamp NOT NULL,
primary_completion_date timestamp without time zone, primary_completion_date timestamp without time zone,
primary_completion_date_category history.updatable_catetories, primary_completion_date_category history.updatable_catetories,
start_date timestamp without time zone, start_date timestamp without time zone,
@ -107,21 +106,11 @@ CREATE TABLE IF NOT EXISTS history.trial_snapshots
overall_status history.study_statuses, overall_status history.study_statuses,
enrollment integer, enrollment integer,
enrollment_category history.updatable_catetories, enrollment_category history.updatable_catetories,
sponsor character varying COLLATE pg_catalog."default", sponsor character varying(255) COLLATE pg_catalog."default",
responsible_party character varying COLLATE pg_catalog."default", responsible_party character varying(255) COLLATE pg_catalog."default",
CONSTRAINT trial_snapshots_pkey PRIMARY KEY (nct_id, version) CONSTRAINT trial_snapshots_pkey PRIMARY KEY (nct_id, version)
); );
ALTER TABLE IF EXISTS history.trial_snapshots ALTER TABLE IF EXISTS history.trial_snapshots
OWNER to root; OWNER to root;
CREATE OR REPLACE VIEW history.match_drugs_to_trials
AS SELECT bi.nct_id,
rp.rxcui,
rp.propvalue1
FROM ctgov.browse_interventions bi
JOIN rxnorm_migrated.rxnorm_props rp ON bi.downcase_mesh_term::text = rp.propvalue1::text
WHERE rp.propname::text = 'RxNorm Name'::text AND (bi.nct_id::text IN ( SELECT trial_snapshots.nct_id
FROM history.trial_snapshots));

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containers/AACT_downloader/docker-entrypoint-initdb.d/999_ntfy.sh
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#!/bin/bash
wget --post-data="postgres complete:$(date)" -qO- https://ntfy.sh/$NTFY > /dev/null

6
containers/RxNav-In-a-box/rxnav-in-a-box-20230103/mysql/999_ntfy.sh
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#!/bin/bash
#install wget
apt update
apt install -y wget
#send notification
wget --post-data="mariadb complete:$(date)" -qO- https://ntfy.sh/$NTFY > /dev/null

2
containers/docker-compose.yaml
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@ -26,7 +26,7 @@ services:
- ./AACT_downloader/aact_downloads/postgres_data.dmp:/mnt/host_data/postgres_data.dmp - ./AACT_downloader/aact_downloads/postgres_data.dmp:/mnt/host_data/postgres_data.dmp
# this is the folder containing entrypoint info. # this is the folder containing entrypoint info.
- ./AACT_downloader/docker-entrypoint-initdb.d/:/docker-entrypoint-initdb.d/ - ./AACT_downloader/docker-entrypoint-initdb.d/:/docker-entrypoint-initdb.d/
shm_size: 512mb shm-size: 1g
rxnav-db: rxnav-db:

44
data_mgmt_scripts/Icd10ConditionsMatching/Icd10ConditionsMatching/__init__.py
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from flask import Flask
import os
from dotenv import dotenv_values
env_path = "../../containers/.env"
ENV = dotenv_values(env_path)
def create_app(test_config=None):
# create and configure the app
app = Flask(__name__, instance_relative_config=True)
app.config.from_mapping(
SECRET_KEY='6e674d6e41b733270fd01c6257b3a1b4769eb80f3f773cd0fe8eff25f350fc1f',
POSTGRES_DB=ENV["POSTGRES_DB"],
POSTGRES_USER=ENV["POSTGRES_USER"],
POSTGRES_HOST=ENV["POSTGRES_HOST"],
POSTGRES_PORT=ENV["POSTGRES_PORT"],
POSTGRES_PASSWORD=ENV["POSTGRES_PASSWORD"],
)
# ensure the instance folder exists
try:
os.makedirs(app.instance_path)
except OSError:
pass
# a simple page that says hello
@app.route('/')
def hello():
return 'Hello, World!'
from . import db_interface
db_interface.init_database(app)
from . import validation
app.register_blueprint(validation.bp)
return app

175
data_mgmt_scripts/Icd10ConditionsMatching/Icd10ConditionsMatching/db_interface.py
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import psycopg2 as psyco
from psycopg2 import extras
from datetime import datetime
import click #used for cli commands. Not needed for what I am doing.
from flask import current_app, g
def get_db(**kwargs):
if "db" not in g:
g.db = psyco.connect(
dbname=current_app.config["POSTGRES_DB"]
,user=current_app.config["POSTGRES_USER"]
,host=current_app.config["POSTGRES_HOST"]
,port=current_app.config["POSTGRES_PORT"]
,password=current_app.config["POSTGRES_PASSWORD"]
,**kwargs
)
return g.db
def close_db(e=None):
db = g.pop('db', None)
if db is not None:
db.close()
def check_initialization(app):
db = get_db()
with db.cursor() as curse:
curse.execute("select count(*) from \"DiseaseBurden\".trial_to_icd10")
curse.fetchall()
#just checking if everything is going to fail
def init_database(app):
#check_initialization(app)
app.teardown_appcontext(close_db)
def select_remaing_trials_to_analyze(db_conn):
'''
This will get the set of trials that need to be analyzed.
'''
sql = '''
select distinct nct_id
from "DiseaseBurden".trial_to_icd10 tti
where tti.approved is null
order by nct_id
;
'''
with db_conn.cursor() as cursor:
cursor.execute(sql)
return cursor.fetchall()
def select_analyzed_trials(db_conn):
'''
This will get the set of trials that have been analyzed.
'''
sql = '''
select distinct nct_id, max(approval_timestamp)
from "DiseaseBurden".trial_to_icd10 tti
where tti.approved in ('accepted','rejected')
group by nct_id
order by max(approval_timestamp) desc
;
'''
with db_conn.cursor() as cursor:
cursor.execute(sql)
return cursor.fetchall()
def select_unmatched_trials(db_conn):
'''
This will get the set of trials that have been analyzed.
'''
sql = '''
select distinct nct_id
from "DiseaseBurden".trial_to_icd10 tti
where tti.approved = 'unmatched'
order by nct_id
;
'''
with db_conn.cursor() as cursor:
cursor.execute(sql)
return cursor.fetchall()
def get_trial_conditions_and_proposed_matches(db_conn, nct_id):
sql = '''
select *
from "DiseaseBurden".trial_to_icd10 tti
where nct_id = %s
'''
with db_conn.cursor() as cursor:
cursor.execute(sql,[nct_id])
return cursor.fetchall()
def store_validation(db_conn, list_of_insert_data):
sql = """
update "DiseaseBurden".trial_to_icd10
set approved=%s, approval_timestamp=%s
where id=%s
;
"""
with db_conn.cursor() as cursor:
for l in list_of_insert_data:
cursor.execute(sql, l)
db_conn.commit()
def get_trial_summary(db_conn,nct_id):
sql_summary ="""
select
s.nct_id,
brief_title ,
official_title ,
bs.description as brief_description,
dd.description as detailed_description
from ctgov.studies s
left join ctgov.brief_summaries bs
on bs.nct_id = s.nct_id
left join ctgov.detailed_descriptions dd
on dd.nct_id = s.nct_id
where s.nct_id = %s
;
"""
sql_conditions="""
--conditions mentioned
select * from ctgov.conditions c
where c.nct_id = %s
;
"""
sql_keywords="""
select nct_id ,downcase_name
from ctgov.keywords k
where k.nct_id = %s
;
"""
with db_conn.cursor() as curse:
curse.execute(sql_summary,[nct_id])
summary = curse.fetchall()
curse.execute(sql_keywords,[nct_id])
keywords = curse.fetchall()
curse.execute(sql_conditions,[nct_id])
conditions = curse.fetchall()
return {"summary":summary, "keywords":keywords, "conditions":conditions}
def get_list_icd10_codes(db_conn):
sql = """
select distinct code
from "DiseaseBurden".icd10_to_cause itc
order by code;
"""
with db_conn.cursor() as curse:
curse.execute(sql)
codes = curse.fetchall()
return [ x[0] for x in codes ]
def record_suggested_matches(db_conn, nct_id,condition,icd10_code):
sql1 = """
INSERT INTO "DiseaseBurden".trial_to_icd10
(nct_id,"condition",ui,"source",approved,approval_timestamp)
VALUES (%s,%s,%s,'hand matched','accepted',%s)
;
"""
with db_conn.cursor() as curse:
curse.execute(sql1,[nct_id,condition,icd10_code,datetime.now()])
db_conn.commit()

1
data_mgmt_scripts/Icd10ConditionsMatching/Icd10ConditionsMatching/login.py
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#at some point I need to add a login or something.

25
data_mgmt_scripts/Icd10ConditionsMatching/Icd10ConditionsMatching/templates/base.html
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<!doctype html>
<title>{% block title %}{% endblock %} - ClinicalTrialsProject</title>
<!--<link rel="stylesheet" href="{{ url_for('static', filename='style.css') }}">-->
<nav>
<h1>Nav</h1>
<ul>
<li>
<a href="{{ url_for('validation.remaining') }}">Validation Home</a>
</li>
<li>
<a href="https://icd.who.int/browse10/2019/en">WHO ICD-10 Codes (2019)</a>
</li>
<li>
<a href="https://uts.nlm.nih.gov/uts/umls/home">UMLS Metathesaurs browser (requires login)</a>
</li>
</ul>
</nav>
<section class="content">
<header>
{% block header %}{% endblock %}
</header>
{% block content %}{% endblock %}
</section>

49
data_mgmt_scripts/Icd10ConditionsMatching/Icd10ConditionsMatching/templates/validation_index.html
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{% extends 'base.html' %}
{% block header %}
<h1>{% block title %} ICD-10 to Trial Conditions Validation {% endblock %}</h1>
{% endblock %}
{% block content %}
<h2>Trials to Validate</h2>
<table>
<th>Trials</th>
{% for trial in list_to_validate %}
<tr><td>
<a href="{{ url_for('.validate_trial', nct_id=trial[0] ) }}">
{{ trial [0] }}
</a>
</td></tr>
{% endfor %}
</table>
<h2>Trials that have been Validated</h2>
<table>
<th>Trials Links</th>
{% for trial in validated_list %}
<tr><td>
<a href="{{ url_for('.validate_trial', nct_id=trial[0] ) }}">
{{ trial [0] }}
</a>
(Most recently updated {{trial[1]}})
</td></tr>
{% endfor %}
</table>
<h2>Trials that don't have a good match</h2>
<table>
<th>Trial Links</th>
{% for trial in unmatched_list %}
<tr><td>
<a href="{{ url_for('.validate_trial', nct_id=trial[0] ) }}">
{{ trial [0] }}
</a>
</td></tr>
{% endfor %}
</table>
{% endblock %}

95
data_mgmt_scripts/Icd10ConditionsMatching/Icd10ConditionsMatching/templates/validation_of_trial.html
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{% extends 'base.html' %}
{% block header %}
<h1> ICD-10 to Trial Conditions Validation: {{ nct_id }} </h1>
{% endblock %}
{% block content %}
<section class="summary">
<h3>Trial Summary</h3>
<div class="text_summary">
<ul>
<li>NCT: {{ summary_dats["summary"][0][0] }}</li>
<li>Brief Title: {{ summary_dats["summary"][0][1] }}</li>
<li>Long Title: {{ summary_dats["summary"][0][2] }}</li>
<li>Brief Description: {{ summary_dats["summary"][0][3] }}</li>
<li>Long Description: {{ summary_dats["summary"][0][4] }}</li>
</ul>
</div>
<div class="keywords">
<h4>Keywords</h4>
<ul>
{% for keyword in summary_dats["keywords"] %}
<li>
{{ keyword[1] }}
</li>
{% endfor %}
</ul>
</div>
<div class="conditions">
<h4>Raw Conditions </h4>
<ul>
{% for condition in summary_dats["conditions"] %}
<li>
{{ condition[3] }}
</li>
{% endfor %}
</ul>
</div>
</section>
<section class="proposed_conditions">
<h3>Proposed Conditions</h3>
<form method="post">
<table>
<tr>
<th>Approve</th>
<th>Condition (MeSH normalized)</th>
<th>Identifier</th>
<th>Source</th>
<th>Description</th>
<th>Source</th>
</tr>
{% for condition in condition_list %}
<tr>
<td> <input type="checkbox" id="{{ condition[0] }}" name="{{condition[0]}}" value="accepted" {% if condition[8] == "accepted" %}checked{% endif %}> </td>
<td> {{condition[2]}} </td>
<td> {{condition[3]}} </td>
<td> {{condition[5]}} </td>
<td> {{condition[6]}} </td>
<td> {{condition[7]}} </td>
</tr>
{% endfor %}
</table>
<input type="submit" name="submission" value="Submit approvals">
<br/>
<input type="submit" name="marked_unmatched" value="Mark unmmatched">
</form>
</section>
<section class="submit_alternate">
<h3>Submit Alternate Conditions</h3>
<!--For each listed condition, provide a spot to enter a ICT10 code-->
<form method="post">
<label for="alternate_sub">Please enter the proposed code that appears to be the best match:</label>
<input name="alt_sub" id="alternate_sub">
<br/>
<label for="condition">
Please give a name to the condition you used to match this<br/>
Condition:
</label>
<input name="condition", id="condition">
<br/>
<input type="submit" name="alternate_submission" value="Submit alternate ICD-10 code">
</form>
</section>
<section class="approved">
<!--TODO:This will list the already approved values-->
</section>
{% endblock %}

98
data_mgmt_scripts/Icd10ConditionsMatching/Icd10ConditionsMatching/validation.py
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import functools
from flask import (Blueprint, flash, g, redirect, render_template, request, session, url_for)
from Icd10ConditionsMatching.db_interface import (
get_db,select_remaing_trials_to_analyze,
select_analyzed_trials,
select_unmatched_trials,
get_trial_conditions_and_proposed_matches,
store_validation,
get_trial_summary,
get_list_icd10_codes,
record_suggested_matches,
)
from datetime import datetime
#### First Blueprint: Checking Data
bp = Blueprint("validation", __name__, url_prefix="/validation")
@bp.route("/",methods=["GET"])
def remaining():
db_conn = get_db()
to_validate = select_remaing_trials_to_analyze(db_conn)
validated = select_analyzed_trials(db_conn)
unmatched_list = select_unmatched_trials(db_conn)
return render_template(
"validation_index.html",
list_to_validate=to_validate,
validated_list = validated,
unmatched_list = unmatched_list
)
@bp.route("/<nct_id>", methods=["GET","POST"])
def validate_trial(nct_id):
if request.method == "GET":
db_conn = get_db()
condition_list = get_trial_conditions_and_proposed_matches(db_conn, nct_id)
summary_dats = get_trial_summary(db_conn, nct_id)
return render_template(
"validation_of_trial.html",
nct_id=nct_id,
condition_list=condition_list,
summary_dats=summary_dats,
)
elif request.method == "POST":
db_conn = get_db()
list_of_insert_data = []
db_conn = get_db()
condition_list = get_trial_conditions_and_proposed_matches(db_conn, nct_id)
print(request.form)
if "submission" in request.form:
#if it is a submission:
#grab all match ids from db
#if match id in submitted form, mark as approved, otherwise mark as rejected
for condition in condition_list:
id = condition[0]
list_of_insert_data.append((request.form.get(str(id),"rejected"), datetime.now(),id))
store_validation(db_conn, list_of_insert_data)
return redirect(url_for("validation.remaining"))
elif "marked_unmatched" in request.form:
#if this was marked as "unmatched", store that for each entry.
for condition in condition_list:
id = condition[0]
list_of_insert_data.append(( "unmatched", datetime.now(), id))
store_validation(db_conn, list_of_insert_data)
return redirect(url_for("validation.remaining"))
elif "alternate_submission" in request.form:
code = request.form["alt_sub"]
code = code.strip().replace(".",'').ljust(7,"-")
condition = request.form["condition"].strip()
codelist = get_list_icd10_codes(db_conn)
if code in codelist:
record_suggested_matches(db_conn, nct_id, condition, code)
return redirect(request.path)
else:
record_suggested_matches(db_conn, nct_id, condition + "| Code not in GBD list", code)
return """
Entered `{}`, which is not in the list of available ICD-10 codes. <a href={}>Return to trial summary</a>
""".format(code.strip("-"),request.path), 422

13
data_mgmt_scripts/Icd10ConditionsMatching/setup.py
Unescape Escape View File

@ -1,13 +0,0 @@
from setuptools import setup
setup(
name='Icd10ConditionsMatching',
packages=['Icd10ConditionsMatching'],
include_package_data=True,
install_requires=[
'flask',
'psycopg2',
'datetime',
'python-dotenv',
],
)

1
data_mgmt_scripts/Icd10ConditionsMatching/start.sh
Unescape Escape View File

@ -1 +0,0 @@
waitress-serve --port=5000 --call 'Icd10ConditionsMatching:create_app'

36
data_mgmt_scripts/import-icd10_to_cause.py
Unescape Escape View File

@ -1,36 +0,0 @@
from drugtools.env_setup import ENV,postgres_conn
from psycopg2 import extras
from collections import namedtuple
from tqdm import tqdm
FILES=[
"../non-db_data_sources/GBD and ICD-10_(2019 version)/NONFATAL_cause2code.psv",
"../non-db_data_sources/GBD and ICD-10_(2019 version)/COD_cause2code.psv"
]
SEP="|"
sql = """
INSERT INTO "DiseaseBurden".icd10_to_cause
(code,cause_text)
VALUES %s
"""
with postgres_conn() as pconn, pconn.cursor(cursor_factory=extras.DictCursor) as pcurse:
entries = []
for fpath in FILES:
print(fpath)
with open(fpath,"r") as fh:
for line in tqdm(fh.readlines(),desc=fpath):
code,cause = line.split(SEP)
code = code.strip()
cause = cause.strip()
entries.append((code,cause))
extras.execute_values(pcurse, sql , entries)

5
data_mgmt_scripts/rm_data.sh
Unescape Escape View File

@ -1,5 +0,0 @@
#!/bin/bash
rm -r ../containers/RxNav-In-a-box/rxnav_data/*
rm -r ../containers/AACT_downloader/postgresql/data

24
data_mgmt_scripts/runall.py
Unescape Escape View File

@ -1,24 +0,0 @@
from drugtools import env_setup
from drugtools import historical_trial_selector as hts
from drugtools import historical_nct_downloader as hnd
from drugtools import historical_nct_extractor as hne
from drugtools import download_and_extract_nsde as daen
from drugtools import migrate_mysql2pgsql as mm2p
print("Current Environment")
print(env_setup.ENV)
cont = input("Are you willing to continue with the current environmnet? y/[n]")
if cont == "Y" or cont == "y":
print("SelectingTrials")
#hts.run()
print("downloading trials")
#hnd.run()
print("extracting trials")
hne.run()
exit(0)
daen.run()
mm2p.run()
else:
print("Please fix your .env file and try again")

87
data_mgmt_scripts/umls_requests.py
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@ -1,87 +0,0 @@
import requests
import json
from drugtools.env_setup import ENV,postgres_conn
from psycopg2 import extras
from collections import namedtuple
from tqdm import tqdm
RecordStuff = namedtuple("RecordStuff", "nct_id condition ui uri rootSource name")
class Requestor():
def __init__(self,api_key):
self.key = api_key
def search(self,search_term,inputType="sourceUi", returnIdType="code", addnl_terms={}):
query_terms = {
"apiKey":self.key,
"sabs":"ICD10",
"string":search_term,
"returnIdType":returnIdType,
"inputType":inputType
} | addnl_terms
query = "https://uts-ws.nlm.nih.gov/rest/search/current/"
r = requests.get(query,params=query_terms)
return r
r = Requestor(ENV.get("UMLS_API_KEY"))
with postgres_conn() as pconn, pconn.cursor(cursor_factory=extras.DictCursor) as pcurse:
sql = """
select nct_id, downcase_mesh_term
from ctgov.browse_conditions bc
where
mesh_type = 'mesh-list'
and
nct_id in (select distinct nct_id from history.trial_snapshots ts)
order by nct_id
;
"""
sql2 = """
with cte as (
/* Keywords added too much noise
select nct_id,downcase_name
from ctgov.keywords k
where nct_id in (select distinct nct_id from history.trial_snapshots ts)
union */
select nct_id, downcase_name
from ctgov.conditions c
union
select nct_id ,downcase_mesh_term as downcase_name
from ctgov.browse_conditions bc
where mesh_type = 'mesh-list'
)
select nct_id, downcase_name from cte
where nct_id in (select distinct nct_id from history.trial_snapshots ts)
order by nct_id
"""
pcurse.execute(sql2)
rows = pcurse.fetchall()
entries = []
for row in tqdm(rows,desc="Search MeSH terms"):
nctid = row[0]
condition = row[1]
# print(nctid,condition)
results = r.search(row[1]).json().get('result', Exception("No result entry in json")).get('results',Exception("No results entry in json"))
#if results are empty?
if not results:
entries.append(RecordStuff(nctid,condition,None,None,None,None))
else:
for entry in results:
entries.append(RecordStuff(nctid, condition, entry["ui"], entry["uri"], entry["rootSource"], entry["name"]))
sql_insert = """
INSERT INTO "DiseaseBurden".trial_to_icd10
(nct_id, "condition", ui,uri,rootsource,"name","source",approved,approval_timestamp)
VALUES
(%(nct_id)s, %(condition)s, %(ui)s, %(uri)s, %(rootSource)s, %(name)s, 'UMLS API search', null,null)
"""
for entry in tqdm(entries,desc="Inserting entries to DB"):
pcurse.execute(sql_insert,entry._asdict())

58
Scripts/ASSOICATING NCTIDs to NDCs and Marketing dates.sql → development_sql/ASSOICATING NCTIDs to NDCs and Marketing dates.sql
Unescape Escape View File

@ -16,8 +16,8 @@ SELECT
bi.nct_id , bi.nct_id ,
bi.downcase_mesh_term, bi.downcase_mesh_term,
rr.tty2 , rr.tty2 ,
rr.rxcui2 as bn_or_in_cui, --brand or ingredient rr.rxcui2 as bn_or_in_cui --brand or ingredient
count(*) ,count(*)
FROM ctgov.browse_interventions bi FROM ctgov.browse_interventions bi
left outer JOIN rxnorm_migrated.rxnorm_props AS rp left outer JOIN rxnorm_migrated.rxnorm_props AS rp
on bi.downcase_mesh_term = rp.propvalue1 --link names to drug cuis () on bi.downcase_mesh_term = rp.propvalue1 --link names to drug cuis ()
@ -34,53 +34,6 @@ WHERE
group by bi.nct_id, bi.downcase_mesh_term , rr.tty2 ,rr.rxcui2 group by bi.nct_id, bi.downcase_mesh_term , rr.tty2 ,rr.rxcui2
order by bi.nct_id order by bi.nct_id
; ;
--running out of space.
-- get list of interventions assoicated with trials of interest
create temp table tmp_interventions as
select * from ctgov.browse_interventions bi
where
bi.mesh_type ='mesh-list'
and
bi.nct_id in (select distinct nct_id from history.trial_snapshots)
;
select * from tmp_interventions;
--drop table tmp_join_interv_rxcui;
create temp table tmp_join_interv_rxcui as
select *
from
tmp_interventions tint
inner join
rxnorm_migrated.rxnorm_props rp
on tint.downcase_mesh_term = rp.propvalue1
where propname='RxNorm Name'
;-- get the rxcui for ingredients
select * from tmp_join_interv_rxcui;
--filter rxcui -> is human prescribable
create temp view tmp_view_prescribable as
select count(*) from rxnorm_migrated.rxnorm_props rp
where
rp.propname = 'PRESCRIBABLE'
and
rp.propvalue1 = 'Y'
;
--link prescribable to brand ingredients or brand names.
--get relationships of IN -> BN
select *
from
rxnorm_migrated.rxnorm_relations rr
where
rr.tty1 in ('IN','MIN')
and rr.rxcui1 in (select distinct rxcui from tmp_join_interv_rxcui tjir)
and rr.tty2 = 'BN'
;
--match trials to through brands NDC11 --match trials to through brands NDC11
@ -123,11 +76,4 @@ group by mttn.nct_id,n.application_number_or_citation
order by mttn.nct_id order by mttn.nct_id
; ;
---Number of trials after a certain date
select nct_id,count(distinct application_number_or_citation)
from public.match_trial_to_marketing_start_date mttmsd
where "min" > '2012-06-01'
group by nct_id
;

0
data_mgmt_scripts/Icd10ConditionsMatching/Icd10ConditionsMatching/model.py → development_sql/Script.sql
Unescape Escape View File

0
Scripts/views to history.sql → development_sql/views to history.sql
Unescape Escape View File

6
export/export_data_postgres_materialized_views.sql
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@ -1,6 +0,0 @@
SELECT
'CREATE OR REPLACE MATERIALIZED VIEW ' || schemaname || '.' || viewname || ' AS ' || definition
FROM pg_views
WHERE schemaname != 'pg_catalog'
and schemaname != 'information_schema'
;

24
export/export_data_postgres_tables.sql
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@ -1,24 +0,0 @@
SELECT
'CREATE TABLE ' || schemaname || '.' || tablename || E'\n(\n' ||
string_agg(column_definition, E',\n') || E'\n);\n'
FROM (
SELECT
schemaname,
tablename,
column_name || ' ' || data_type ||
CASE
WHEN character_maximum_length IS NOT NULL THEN '(' || character_maximum_length || ')'
ELSE ''
END ||
CASE
WHEN is_nullable = 'NO' THEN ' NOT NULL'
ELSE ''
END as column_definition
FROM pg_catalog.pg_tables t
JOIN information_schema.columns c
ON t.schemaname = c.table_schema
AND t.tablename = c.table_name
WHERE schemaname != 'pg_catalog'
and schemaname != 'information_schema'-- Replace with your schema name
) t
GROUP BY schemaname, tablename;

6
export/export_data_postgres_views.sql
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@ -1,6 +0,0 @@
SELECT
'CREATE OR REPLACE VIEW ' || schemaname || '.' || viewname || ' AS ' || definition
FROM pg_views
WHERE schemaname != 'pg_catalog'
and schemaname != 'information_schema' -- Replace with your schema name
;

415
export/output_2025-01-06_export_data_postgres_materialized_views.sql
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@ -1,415 +0,0 @@
?column?
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_browse_conditions AS SELECT browse_conditions.nct_id, +
array_to_string(array_agg(DISTINCT browse_conditions.mesh_term), '|'::text) AS names +
FROM ctgov.browse_conditions +
GROUP BY browse_conditions.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_browse_interventions AS SELECT browse_interventions.nct_id, +
array_to_string(array_agg(browse_interventions.mesh_term), '|'::text) AS names +
FROM ctgov.browse_interventions +
GROUP BY browse_interventions.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_cities AS SELECT facilities.nct_id, +
array_to_string(array_agg(DISTINCT facilities.city), '|'::text) AS names +
FROM ctgov.facilities +
GROUP BY facilities.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_conditions AS SELECT conditions.nct_id, +
array_to_string(array_agg(DISTINCT conditions.name), '|'::text) AS names +
FROM ctgov.conditions +
GROUP BY conditions.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_countries AS SELECT countries.nct_id, +
array_to_string(array_agg(DISTINCT countries.name), '|'::text) AS names +
FROM ctgov.countries +
WHERE (countries.removed IS NOT TRUE) +
GROUP BY countries.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_design_outcomes AS SELECT design_outcomes.nct_id, +
array_to_string(array_agg(DISTINCT design_outcomes.measure), '|'::text) AS names +
FROM ctgov.design_outcomes +
GROUP BY design_outcomes.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_facilities AS SELECT facilities.nct_id, +
array_to_string(array_agg(facilities.name), '|'::text) AS names +
FROM ctgov.facilities +
GROUP BY facilities.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_group_types AS SELECT design_groups.nct_id, +
array_to_string(array_agg(DISTINCT design_groups.group_type), '|'::text) AS names +
FROM ctgov.design_groups +
GROUP BY design_groups.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_id_information AS SELECT id_information.nct_id, +
array_to_string(array_agg(DISTINCT id_information.id_value), '|'::text) AS names +
FROM ctgov.id_information +
GROUP BY id_information.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_intervention_types AS SELECT interventions.nct_id, +
array_to_string(array_agg(interventions.intervention_type), '|'::text) AS names +
FROM ctgov.interventions +
GROUP BY interventions.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_interventions AS SELECT interventions.nct_id, +
array_to_string(array_agg(interventions.name), '|'::text) AS names +
FROM ctgov.interventions +
GROUP BY interventions.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_keywords AS SELECT keywords.nct_id, +
array_to_string(array_agg(DISTINCT keywords.name), '|'::text) AS names +
FROM ctgov.keywords +
GROUP BY keywords.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_overall_official_affiliations AS SELECT overall_officials.nct_id, +
array_to_string(array_agg(overall_officials.affiliation), '|'::text) AS names +
FROM ctgov.overall_officials +
GROUP BY overall_officials.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_overall_officials AS SELECT overall_officials.nct_id, +
array_to_string(array_agg(overall_officials.name), '|'::text) AS names +
FROM ctgov.overall_officials +
GROUP BY overall_officials.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_primary_outcome_measures AS SELECT design_outcomes.nct_id, +
array_to_string(array_agg(DISTINCT design_outcomes.measure), '|'::text) AS names +
FROM ctgov.design_outcomes +
WHERE ((design_outcomes.outcome_type)::text = 'primary'::text) +
GROUP BY design_outcomes.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_secondary_outcome_measures AS SELECT design_outcomes.nct_id, +
array_to_string(array_agg(DISTINCT design_outcomes.measure), '|'::text) AS names +
FROM ctgov.design_outcomes +
WHERE ((design_outcomes.outcome_type)::text = 'secondary'::text) +
GROUP BY design_outcomes.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_sponsors AS SELECT sponsors.nct_id, +
array_to_string(array_agg(DISTINCT sponsors.name), '|'::text) AS names +
FROM ctgov.sponsors +
GROUP BY sponsors.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.all_states AS SELECT facilities.nct_id, +
array_to_string(array_agg(DISTINCT facilities.state), '|'::text) AS names +
FROM ctgov.facilities +
GROUP BY facilities.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.categories AS SELECT search_results.id, +
search_results.nct_id, +
search_results.name, +
search_results.created_at, +
search_results.updated_at, +
search_results."grouping", +
search_results.study_search_id +
FROM ctgov.search_results;
CREATE OR REPLACE MATERIALIZED VIEW ctgov.covid_19_studies AS SELECT s.nct_id, +
s.overall_status, +
s.study_type, +
s.official_title, +
s.acronym, +
s.phase, +
s.why_stopped, +
s.has_dmc, +
s.enrollment, +
s.is_fda_regulated_device, +
s.is_fda_regulated_drug, +
s.is_unapproved_device, +
s.has_expanded_access, +
s.study_first_submitted_date, +
s.last_update_posted_date, +
s.results_first_posted_date, +
s.start_date, +
s.primary_completion_date, +
s.completion_date, +
s.study_first_posted_date, +
cv.number_of_facilities, +
cv.has_single_facility, +
cv.nlm_download_date, +
s.number_of_arms, +
s.number_of_groups, +
sp.name AS lead_sponsor, +
aid.names AS other_ids, +
e.gender, +
e.gender_based, +
e.gender_description, +
e.population, +
e.minimum_age, +
e.maximum_age, +
e.criteria, +
e.healthy_volunteers, +
ak.names AS keywords, +
ai.names AS interventions, +
ac.names AS conditions, +
d.primary_purpose, +
d.allocation, +
d.observational_model, +
d.intervention_model, +
d.masking, +
d.subject_masked, +
d.caregiver_masked, +
d.investigator_masked, +
d.outcomes_assessor_masked, +
ado.names AS design_outcomes, +
bs.description AS brief_summary, +
dd.description AS detailed_description +
FROM (((((((((((ctgov.studies s +
FULL JOIN ctgov.all_conditions ac ON (((s.nct_id)::text = (ac.nct_id)::text))) +
FULL JOIN ctgov.all_id_information aid ON (((s.nct_id)::text = (aid.nct_id)::text))) +
FULL JOIN ctgov.all_design_outcomes ado ON (((s.nct_id)::text = (ado.nct_id)::text))) +
FULL JOIN ctgov.all_keywords ak ON (((s.nct_id)::text = (ak.nct_id)::text))) +
FULL JOIN ctgov.all_interventions ai ON (((s.nct_id)::text = (ai.nct_id)::text))) +
FULL JOIN ctgov.sponsors sp ON (((s.nct_id)::text = (sp.nct_id)::text))) +
FULL JOIN ctgov.calculated_values cv ON (((s.nct_id)::text = (cv.nct_id)::text))) +
FULL JOIN ctgov.designs d ON (((s.nct_id)::text = (d.nct_id)::text))) +
FULL JOIN ctgov.eligibilities e ON (((s.nct_id)::text = (e.nct_id)::text))) +
FULL JOIN ctgov.brief_summaries bs ON (((s.nct_id)::text = (bs.nct_id)::text))) +
FULL JOIN ctgov.detailed_descriptions dd ON (((s.nct_id)::text = (dd.nct_id)::text))) +
WHERE (((sp.lead_or_collaborator)::text = 'lead'::text) AND ((s.nct_id)::text IN ( SELECT search_results.nct_id +
FROM ctgov.search_results +
WHERE ((search_results.name)::text = 'covid-19'::text))));
CREATE OR REPLACE MATERIALIZED VIEW history.match_drugs_to_trials AS SELECT bi.nct_id, +
rp.rxcui, +
rp.propvalue1 +
FROM (ctgov.browse_interventions bi +
JOIN rxnorm_migrated.rxnorm_props rp ON (((bi.downcase_mesh_term)::text = (rp.propvalue1)::text))) +
WHERE (((rp.propname)::text = 'RxNorm Name'::text) AND ((bi.nct_id)::text IN ( SELECT trial_snapshots.nct_id +
FROM history.trial_snapshots)));
CREATE OR REPLACE MATERIALIZED VIEW http.most_recent_download_status AS SELECT t.nct_id, +
t.status, +
t.update_timestamp +
FROM ( SELECT download_status.id, +
download_status.nct_id, +
download_status.status, +
download_status.update_timestamp, +
row_number() OVER (PARTITION BY download_status.nct_id ORDER BY download_status.update_timestamp DESC) AS rn +
FROM http.download_status) t +
WHERE (t.rn = 1) +
ORDER BY t.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW public.time_between_submission_and_start_view AS SELECT s.nct_id, +
s.start_date, +
ts.version, +
ts.submission_date, +
abs(((EXTRACT(epoch FROM (ts.submission_date - (s.start_date)::timestamp without time zone)))::double precision / (((24 * 60) * 60))::double precision)) AS start_deviance +
FROM (ctgov.studies s +
JOIN history.trial_snapshots ts ON (((s.nct_id)::text = (ts.nct_id)::text))) +
WHERE ((s.nct_id)::text IN ( SELECT DISTINCT tti.nct_id +
FROM "DiseaseBurden".trial_to_icd10 tti));
CREATE OR REPLACE MATERIALIZED VIEW public.rank_proximity_to_start_time_view AS SELECT cte.nct_id, +
cte.version, +
row_number() OVER (PARTITION BY cte.nct_id ORDER BY cte.start_deviance) AS rownum, +
cte.submission_date, +
cte.start_deviance, +
cte.start_date, +
ts.primary_completion_date, +
ts.primary_completion_date_category, +
ts.overall_status, +
ts.enrollment, +
ts.enrollment_category +
FROM (time_between_submission_and_start_view cte +
JOIN history.trial_snapshots ts ON ((((cte.nct_id)::text = (ts.nct_id)::text) AND (cte.version = ts.version))));
CREATE OR REPLACE MATERIALIZED VIEW public.enrollment_closest_to_start_view AS SELECT cte2.nct_id, +
min(cte2.rownum) AS enrollment_source +
FROM rank_proximity_to_start_time_view cte2 +
WHERE (cte2.enrollment IS NOT NULL) +
GROUP BY cte2.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW public.match_trials_to_bn_in AS WITH trialncts AS ( +
SELECT DISTINCT ts.nct_id +
FROM history.trial_snapshots ts +
) +
SELECT bi.nct_id, +
bi.downcase_mesh_term, +
rr.tty2, +
rr.rxcui2 AS bn_or_in_cui, +
count(*) AS count +
FROM ((ctgov.browse_interventions bi +
LEFT JOIN rxnorm_migrated.rxnorm_props rp ON (((bi.downcase_mesh_term)::text = (rp.propvalue1)::text))) +
LEFT JOIN rxnorm_migrated.rxnorm_relations rr ON ((rr.rxcui1 = rp.rxcui))) +
WHERE (((bi.nct_id)::text IN ( SELECT trialncts.nct_id +
FROM trialncts)) AND ((bi.mesh_type)::text = 'mesh-list'::text) AND ((rp.propname)::text = 'Active_ingredient_name'::text) AND (rr.tty2 = ANY (ARRAY['BN'::bpchar, 'IN'::bpchar, 'MIN'::bpchar]))) +
GROUP BY bi.nct_id, bi.downcase_mesh_term, rr.tty2, rr.rxcui2 +
ORDER BY bi.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW public.match_trial_to_ndc11 AS SELECT mttbi.nct_id, +
ah.ndc, +
count(*) AS count +
FROM ((match_trials_to_bn_in mttbi +
LEFT JOIN rxnorm_migrated.rxnorm_relations rr ON ((mttbi.bn_or_in_cui = rr.rxcui1))) +
LEFT JOIN rxnorm_migrated."ALLNDC_HISTORY" ah ON ((rr.rxcui2 = ah.rxcui))) +
WHERE ((rr.tty1 = 'BN'::bpchar) AND (rr.tty2 = ANY (ARRAY['SBD'::bpchar, 'BPCK'::bpchar])) AND ((ah.sab)::text = 'RXNORM'::text)) +
GROUP BY mttbi.nct_id, ah.ndc +
ORDER BY mttbi.nct_id, ah.ndc;
CREATE OR REPLACE MATERIALIZED VIEW public.match_trial_to_marketing_start_date AS SELECT mttn.nct_id, +
n.application_number_or_citation, +
min(n.marketing_start_date) AS min +
FROM (match_trial_to_ndc11 mttn +
JOIN spl.nsde n ON ((mttn.ndc = (n.package_ndc11)::bpchar))) +
WHERE (((n.product_type)::text = 'HUMAN PRESCRIPTION DRUG'::text) AND ((n.marketing_category)::text = ANY (ARRAY[('NDA'::character varying)::text, ('ANDA'::character varying)::text, ('BLA'::character varying)::text, ('NDA authorized generic'::character varying)::text, ('NDA AUTHORIZED GENERIC'::character varying)::text]))) +
GROUP BY mttn.nct_id, n.application_number_or_citation +
ORDER BY mttn.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW public.view_burdens_cte AS SELECT b.measure_id, +
b.location_id, +
b.sex_id, +
b.age_id, +
b.cause_id, +
b.metric_id, +
b.year, +
b.val, +
b.upper_95, +
b.lower_95, +
b.key_column +
FROM "DiseaseBurden".burdens b +
WHERE ((b.sex_id = 3) AND (b.metric_id = 1) AND (b.measure_id = 2) AND (b.age_id = 22));
CREATE OR REPLACE MATERIALIZED VIEW public.view_burdens_cte2 AS SELECT c1.cause_id, +
c1.year, +
c1.val AS h_sdi_val, +
c1.upper_95 AS h_sdi_u95, +
c1.lower_95 AS h_sdi_l95, +
c2.val AS hm_sdi_val, +
c2.upper_95 AS hm_sdi_u95, +
c2.lower_95 AS hm_sdi_l95, +
c3.val AS m_sdi_val, +
c3.upper_95 AS m_sdi_u95, +
c3.lower_95 AS m_sdi_l95, +
c4.val AS lm_sdi_val, +
c4.upper_95 AS lm_sdi_u95, +
c4.lower_95 AS lm_sdi_l95, +
c5.val AS l_sdi_val, +
c5.upper_95 AS l_sdi_u95, +
c5.lower_95 AS l_sdi_l95 +
FROM ((((view_burdens_cte c1 +
JOIN view_burdens_cte c2 ON (((c1.cause_id = c2.cause_id) AND (c1.year = c2.year)))) +
JOIN view_burdens_cte c3 ON (((c1.cause_id = c3.cause_id) AND (c1.year = c3.year)))) +
JOIN view_burdens_cte c4 ON (((c1.cause_id = c4.cause_id) AND (c1.year = c4.year)))) +
JOIN view_burdens_cte c5 ON (((c1.cause_id = c5.cause_id) AND (c1.year = c5.year)))) +
WHERE ((c1.location_id = 44635) AND (c2.location_id = 44634) AND (c3.location_id = 44639) AND (c4.location_id = 44636) AND (c5.location_id = 44637));
CREATE OR REPLACE MATERIALIZED VIEW public.view_cte AS SELECT ts.nct_id, +
ts.primary_completion_date, +
ts.primary_completion_date_category, +
ts.enrollment, +
ts.start_date, +
ts.enrollment_category, +
ts.overall_status, +
min(ts.submission_date) AS earliest_date_observed +
FROM history.trial_snapshots ts +
WHERE (((ts.nct_id)::text IN ( SELECT DISTINCT tti.nct_id +
FROM "DiseaseBurden".trial_to_icd10 tti +
WHERE (tti.approved = 'accepted'::"DiseaseBurden".validation_type))) AND (ts.submission_date >= ts.start_date) AND (ts.overall_status <> ALL (ARRAY['Completed'::history.study_statuses, 'Terminated'::history.study_statuses]))) +
GROUP BY ts.nct_id, ts.primary_completion_date, ts.primary_completion_date_category, ts.start_date, ts.enrollment, ts.enrollment_category, ts.overall_status;
CREATE OR REPLACE MATERIALIZED VIEW public.view_disbur_cte0 AS SELECT tti.nct_id, +
tti.ui, +
tti.condition, +
itc.cause_text, +
ch.cause_id, +
ch.level +
FROM (("DiseaseBurden".trial_to_icd10 tti +
JOIN "DiseaseBurden".icd10_to_cause itc ON ((replace(replace((tti.ui)::text, '-'::text, ''::text), '.'::text, ''::text) = replace(replace((itc.code)::text, '-'::text, ''::text), '.'::text, ''::text)))) +
JOIN "DiseaseBurden".cause_hierarchy ch ON (((itc.cause_text)::text = (ch.cause_name)::text))) +
WHERE (tti.approved = 'accepted'::"DiseaseBurden".validation_type);
CREATE OR REPLACE MATERIALIZED VIEW public.view_disbur_cte AS SELECT view_disbur_cte0.nct_id, +
max(view_disbur_cte0.level) AS max_level +
FROM view_disbur_cte0 +
GROUP BY view_disbur_cte0.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW public.view_trial_to_cause AS SELECT tti.nct_id, +
tti.ui, +
tti.condition, +
itc.cause_text, +
ch.cause_id, +
ch.level +
FROM (("DiseaseBurden".trial_to_icd10 tti +
JOIN "DiseaseBurden".icd10_to_cause itc ON ((replace(replace((tti.ui)::text, '-'::text, ''::text), '.'::text, ''::text) = replace(replace((itc.code)::text, '-'::text, ''::text), '.'::text, ''::text)))) +
JOIN "DiseaseBurden".cause_hierarchy ch ON (((itc.cause_text)::text = (ch.cause_name)::text))) +
WHERE (tti.approved = 'accepted'::"DiseaseBurden".validation_type) +
ORDER BY tti.nct_id;
CREATE OR REPLACE MATERIALIZED VIEW public.view_disbur_cte2 AS SELECT ttc.nct_id, +
ttc.ui, +
ttc.condition, +
ttc.cause_text, +
ttc.cause_id, +
disbur_cte.max_level +
FROM (view_trial_to_cause ttc +
JOIN view_disbur_cte disbur_cte ON (((disbur_cte.nct_id)::text = (ttc.nct_id)::text))) +
WHERE (ttc.level = disbur_cte.max_level) +
GROUP BY ttc.nct_id, ttc.ui, ttc.condition, ttc.cause_text, ttc.cause_id, disbur_cte.max_level +
ORDER BY ttc.nct_id, ttc.ui;
CREATE OR REPLACE MATERIALIZED VIEW public.view_disbur_cte3 AS SELECT disbur_cte2.nct_id, +
SUBSTRING(disbur_cte2.ui FROM 1 FOR 3) AS code, +
disbur_cte2.condition, +
disbur_cte2.cause_text, +
disbur_cte2.cause_id, +
ic.chapter_code AS category_id, +
ic.group_name, +
disbur_cte2.max_level +
FROM (view_disbur_cte2 disbur_cte2 +
JOIN "DiseaseBurden".icd10_categories ic ON (((SUBSTRING(disbur_cte2.ui FROM 1 FOR 3) <= (ic.end_code)::text) AND (SUBSTRING(disbur_cte2.ui FROM 1 FOR 3) >= (ic.start_code)::text)))) +
WHERE (ic.level = 1);
CREATE OR REPLACE MATERIALIZED VIEW public.formatted_data AS SELECT cte.nct_id, +
cte.start_date, +
cte.enrollment AS current_enrollment, +
cte.enrollment_category, +
cte.overall_status AS current_status, +
cte.earliest_date_observed, +
(EXTRACT(epoch FROM (cte.earliest_date_observed - cte.start_date)) / EXTRACT(epoch FROM (cte.primary_completion_date - cte.start_date))) AS elapsed_duration, +
count(DISTINCT mttmsd.application_number_or_citation) AS n_brands, +
dbc3.code, +
dbc3.condition, +
dbc3.cause_text, +
dbc3.cause_id, +
dbc3.category_id, +
dbc3.group_name, +
dbc3.max_level, +
b.year, +
b.h_sdi_val, +
b.h_sdi_u95, +
b.h_sdi_l95, +
b.hm_sdi_val, +
b.hm_sdi_u95, +
b.hm_sdi_l95, +
b.m_sdi_val, +
b.m_sdi_u95, +
b.m_sdi_l95, +
b.lm_sdi_val, +
b.lm_sdi_u95, +
b.lm_sdi_l95, +
b.l_sdi_val, +
b.l_sdi_u95, +
b.l_sdi_l95 +
FROM (((view_cte cte +
JOIN match_trial_to_marketing_start_date mttmsd ON (((cte.nct_id)::text = (mttmsd.nct_id)::text))) +
JOIN view_disbur_cte3 dbc3 ON (((dbc3.nct_id)::text = (cte.nct_id)::text))) +
JOIN view_burdens_cte2 b ON (((b.cause_id = dbc3.cause_id) AND (EXTRACT(year FROM b.year) = EXTRACT(year FROM cte.earliest_date_observed))))) +
WHERE (mttmsd.min <= cte.earliest_date_observed) +
GROUP BY cte.nct_id, cte.start_date, cte.enrollment, cte.enrollment_category, cte.overall_status, cte.earliest_date_observed, (EXTRACT(epoch FROM (cte.earliest_date_observed - cte.start_date)) / EXTRACT(epoch FROM (cte.primary_completion_date - cte.start_date))), dbc3.code, dbc3.condition, dbc3.cause_text, dbc3.cause_id, dbc3.category_id, dbc3.group_name, dbc3.max_level, b.cause_id, b.year, b.h_sdi_val, b.h_sdi_u95, b.h_sdi_l95, b.hm_sdi_val, b.hm_sdi_u95, b.hm_sdi_l95, b.m_sdi_val, b.m_sdi_u95, b.m_sdi_l95, b.lm_sdi_val, b.lm_sdi_u95, b.lm_sdi_l95, b.l_sdi_val, b.l_sdi_u95, b.l_sdi_l95+
ORDER BY cte.nct_id, cte.earliest_date_observed;
CREATE OR REPLACE MATERIALIZED VIEW public.formatted_data_with_planned_enrollment AS SELECT f.nct_id, +
f.start_date, +
f.current_enrollment, +
f.enrollment_category, +
f.current_status, +
f.earliest_date_observed, +
f.elapsed_duration, +
f.n_brands, +
f.code, +
f.condition, +
f.cause_text, +
f.cause_id, +
f.category_id, +
f.group_name, +
f.max_level, +
f.year, +
f.h_sdi_val, +
f.h_sdi_u95, +
f.h_sdi_l95, +
f.hm_sdi_val, +
f.hm_sdi_u95, +
f.hm_sdi_l95, +
f.m_sdi_val, +
f.m_sdi_u95, +
f.m_sdi_l95, +
f.lm_sdi_val, +
f.lm_sdi_u95, +
f.lm_sdi_l95, +
f.l_sdi_val, +
f.l_sdi_u95, +
f.l_sdi_l95, +
s.overall_status AS final_status, +
c2a.version, +
c2a.enrollment AS planned_enrollment +
FROM (((formatted_data f +
JOIN ctgov.studies s ON (((f.nct_id)::text = (s.nct_id)::text))) +
JOIN enrollment_closest_to_start_view c3e ON (((c3e.nct_id)::text = (f.nct_id)::text))) +
JOIN rank_proximity_to_start_time_view c2a ON ((((c3e.nct_id)::text = (c2a.nct_id)::text) AND (c3e.enrollment_source = c2a.rownum))));
CREATE OR REPLACE MATERIALIZED VIEW http.trials_to_download AS SELECT most_recent_download_status.nct_id +
FROM http.most_recent_download_status +
WHERE (most_recent_download_status.status = 'Of Interest'::http.history_download_status);
CREATE OR REPLACE MATERIALIZED VIEW public.primary_design_outcomes AS SELECT do2.id, +
do2.nct_id, +
do2.outcome_type, +
do2.measure, +
do2.time_frame, +
do2.population, +
do2.description +
FROM ctgov.design_outcomes do2 +
WHERE (((do2.outcome_type)::text = 'primary'::text) AND ((do2.nct_id)::text IN ( SELECT DISTINCT fd.nct_id +
FROM formatted_data fd)));
(40 rows)

920
export/output_2025-01-06_export_data_postgres_tables.sql
Unescape Escape View File

@ -1,920 +0,0 @@
?column?
-------------------------------------------------------
CREATE TABLE DiseaseBurden.age_group +
( +
id integer NOT NULL, +
age_group character varying NOT NULL +
); +
CREATE TABLE DiseaseBurden.burdens +
( +
measure_id integer NOT NULL, +
location_id integer NOT NULL, +
sex_id integer NOT NULL, +
age_id integer NOT NULL, +
cause_id integer NOT NULL, +
metric_id integer NOT NULL, +
year date NOT NULL, +
val double precision NOT NULL, +
upper_95 double precision NOT NULL, +
lower_95 double precision NOT NULL, +
key_column integer NOT NULL +
); +
CREATE TABLE DiseaseBurden.cause +
( +
id integer NOT NULL, +
cause character varying NOT NULL +
); +
CREATE TABLE DiseaseBurden.cause_hierarchy +
( +
cause_id integer NOT NULL, +
cause_name character varying, +
parent_id integer NOT NULL, +
parent_nae character varying, +
level integer NOT NULL +
); +
CREATE TABLE DiseaseBurden.icd10_categories +
( +
id integer NOT NULL, +
start_code character varying NOT NULL, +
end_code character varying NOT NULL, +
group_name character varying NOT NULL, +
level integer NOT NULL, +
chapter character varying NOT NULL, +
chapter_code integer NOT NULL +
); +
CREATE TABLE DiseaseBurden.icd10_to_cause +
( +
id integer NOT NULL, +
code character varying NOT NULL, +
cause_text character varying NOT NULL +
); +
CREATE TABLE DiseaseBurden.location +
( +
id integer NOT NULL, +
location character varying NOT NULL +
); +
CREATE TABLE DiseaseBurden.measures +
( +
id integer NOT NULL, +
label character varying NOT NULL +
); +
CREATE TABLE DiseaseBurden.metric +
( +
id integer NOT NULL, +
metric_label character varying NOT NULL +
); +
CREATE TABLE DiseaseBurden.rei +
( +
id integer NOT NULL, +
rei_label character varying NOT NULL +
); +
CREATE TABLE DiseaseBurden.sex +
( +
id integer NOT NULL, +
sex character varying NOT NULL +
); +
CREATE TABLE DiseaseBurden.trial_to_icd10 +
( +
id integer NOT NULL, +
nct_id character varying NOT NULL, +
condition character varying NOT NULL, +
ui character varying, +
uri character varying, +
rootsource character varying, +
name character varying, +
source character varying, +
approved USER-DEFINED, +
approval_timestamp timestamp without time zone +
); +
CREATE TABLE Formularies.usp_dc_2023 +
( +
USP Class character varying(250), +
USP Pharmacotherapeutic Group character varying(250),+
API Concept character varying(250), +
rxcui character varying(15), +
tty character varying(10), +
Name character varying(256), +
Related BN character varying(250), +
Related DF character varying(25050), +
USP Category character varying(250) +
); +
CREATE TABLE ctgov.active_storage_attachments +
( +
id bigint NOT NULL, +
name character varying NOT NULL, +
record_type character varying NOT NULL, +
record_id bigint NOT NULL, +
blob_id bigint NOT NULL, +
created_at timestamp without time zone NOT NULL +
); +
CREATE TABLE ctgov.active_storage_blobs +
( +
metadata text, +
checksum character varying NOT NULL, +
byte_size bigint NOT NULL, +
created_at timestamp without time zone NOT NULL, +
id bigint NOT NULL, +
key character varying NOT NULL, +
filename character varying NOT NULL, +
content_type character varying +
); +
CREATE TABLE ctgov.baseline_counts +
( +
count integer, +
nct_id character varying, +
id integer NOT NULL, +
ctgov_group_code character varying, +
units character varying, +
scope character varying, +
result_group_id integer +
); +
CREATE TABLE ctgov.baseline_measurements +
( +
param_value character varying, +
id integer NOT NULL, +
nct_id character varying, +
result_group_id integer, +
ctgov_group_code character varying, +
classification character varying, +
category character varying, +
title character varying, +
description text, +
units character varying, +
param_type character varying, +
param_value_num numeric, +
dispersion_type character varying, +
dispersion_value character varying, +
dispersion_value_num numeric, +
dispersion_lower_limit numeric, +
dispersion_upper_limit numeric, +
explanation_of_na character varying, +
number_analyzed integer, +
number_analyzed_units character varying, +
population_description character varying, +
calculate_percentage character varying +
); +
CREATE TABLE ctgov.brief_summaries +
( +
nct_id character varying, +
id integer NOT NULL, +
description text +
); +
CREATE TABLE ctgov.browse_conditions +
( +
mesh_term character varying, +
id integer NOT NULL, +
mesh_type character varying, +
downcase_mesh_term character varying, +
nct_id character varying +
); +
CREATE TABLE ctgov.browse_interventions +
( +
downcase_mesh_term character varying, +
mesh_term character varying, +
mesh_type character varying, +
id integer NOT NULL, +
nct_id character varying +
); +
CREATE TABLE ctgov.calculated_values +
( +
number_of_secondary_outcomes_to_measure integer, +
maximum_age_unit character varying, +
minimum_age_unit character varying, +
maximum_age_num integer, +
minimum_age_num integer, +
has_single_facility boolean, +
has_us_facility boolean, +
months_to_report_results integer, +
number_of_sae_subjects integer, +
were_results_reported boolean, +
registered_in_calendar_year integer, +
nlm_download_date date, +
actual_duration integer, +
id integer NOT NULL, +
nct_id character varying, +
number_of_facilities integer, +
number_of_nsae_subjects integer, +
number_of_other_outcomes_to_measure integer, +
number_of_primary_outcomes_to_measure integer +
); +
CREATE TABLE ctgov.central_contacts +
( +
phone_extension character varying, +
nct_id character varying, +
role character varying, +
id integer NOT NULL, +
contact_type character varying, +
name character varying, +
phone character varying, +
email character varying +
); +
CREATE TABLE ctgov.conditions +
( +
downcase_name character varying, +
name character varying, +
id integer NOT NULL, +
nct_id character varying +
); +
CREATE TABLE ctgov.countries +
( +
name character varying, +
nct_id character varying, +
id integer NOT NULL, +
removed boolean +
); +
CREATE TABLE ctgov.design_group_interventions +
( +
id integer NOT NULL, +
design_group_id integer, +
intervention_id integer, +
nct_id character varying +
); +
CREATE TABLE ctgov.design_groups +
( +
group_type character varying, +
id integer NOT NULL, +
nct_id character varying, +
title character varying, +
description text +
); +
CREATE TABLE ctgov.design_outcomes +
( +
description text, +
measure text, +
outcome_type character varying, +
nct_id character varying, +
id integer NOT NULL, +
time_frame text, +
population character varying +
); +
CREATE TABLE ctgov.designs +
( +
masking_description text, +
subject_masked boolean, +
caregiver_masked boolean, +
investigator_masked boolean, +
outcomes_assessor_masked boolean, +
id integer NOT NULL, +
nct_id character varying, +
allocation character varying, +
intervention_model character varying, +
observational_model character varying, +
primary_purpose character varying, +
time_perspective character varying, +
masking character varying, +
intervention_model_description text +
); +
CREATE TABLE ctgov.detailed_descriptions +
( +
description text, +
nct_id character varying, +
id integer NOT NULL +
); +
CREATE TABLE ctgov.documents +
( +
comment text, +
id integer NOT NULL, +
url character varying, +
document_type character varying, +
nct_id character varying, +
document_id character varying +
); +
CREATE TABLE ctgov.drop_withdrawals +
( +
period character varying, +
reason character varying, +
count integer, +
ctgov_group_code character varying, +
result_group_id integer, +
nct_id character varying, +
id integer NOT NULL +
); +
CREATE TABLE ctgov.eligibilities +
( +
older_adult boolean, +
id integer NOT NULL, +
nct_id character varying, +
sampling_method character varying, +
gender character varying, +
minimum_age character varying, +
maximum_age character varying, +
healthy_volunteers character varying, +
population text, +
criteria text, +
gender_description text, +
gender_based boolean, +
adult boolean, +
child boolean +
); +
CREATE TABLE ctgov.facilities +
( +
id integer NOT NULL, +
nct_id character varying, +
status character varying, +
name character varying, +
city character varying, +
state character varying, +
zip character varying, +
country character varying +
); +
CREATE TABLE ctgov.facility_contacts +
( +
contact_type character varying, +
name character varying, +
email character varying, +
id integer NOT NULL, +
nct_id character varying, +
phone character varying, +
phone_extension character varying, +
facility_id integer +
); +
CREATE TABLE ctgov.facility_investigators +
( +
nct_id character varying, +
id integer NOT NULL, +
facility_id integer, +
role character varying, +
name character varying +
); +
CREATE TABLE ctgov.file_records +
( +
url character varying, +
id bigint NOT NULL, +
filename character varying, +
file_size bigint, +
file_type character varying, +
created_at timestamp without time zone NOT NULL, +
updated_at timestamp without time zone NOT NULL +
); +
CREATE TABLE ctgov.id_information +
( +
id integer NOT NULL, +
id_source character varying, +
nct_id character varying, +
id_link character varying, +
id_value character varying, +
id_type_description character varying, +
id_type character varying +
); +
CREATE TABLE ctgov.intervention_other_names +
( +
name character varying, +
nct_id character varying, +
intervention_id integer, +
id integer NOT NULL +
); +
CREATE TABLE ctgov.interventions +
( +
id integer NOT NULL, +
name character varying, +
intervention_type character varying, +
description text, +
nct_id character varying +
); +
CREATE TABLE ctgov.ipd_information_types +
( +
name character varying, +
nct_id character varying, +
id integer NOT NULL +
); +
CREATE TABLE ctgov.keywords +
( +
name character varying, +
id integer NOT NULL, +
nct_id character varying, +
downcase_name character varying +
); +
CREATE TABLE ctgov.links +
( +
nct_id character varying, +
id integer NOT NULL, +
description text, +
url character varying +
); +
CREATE TABLE ctgov.mesh_headings +
( +
qualifier character varying, +
id integer NOT NULL, +
subcategory character varying, +
heading character varying +
); +
CREATE TABLE ctgov.mesh_terms +
( +
description character varying, +
tree_number character varying, +
qualifier character varying, +
id integer NOT NULL, +
downcase_mesh_term character varying, +
mesh_term character varying +
); +
CREATE TABLE ctgov.milestones +
( +
count_units character varying, +
count integer, +
description text, +
period character varying, +
title character varying, +
ctgov_group_code character varying, +
result_group_id integer, +
nct_id character varying, +
id integer NOT NULL, +
milestone_description character varying +
); +
CREATE TABLE ctgov.outcome_analyses +
( +
other_analysis_description text, +
param_type character varying, +
non_inferiority_type character varying, +
outcome_id integer, +
nct_id character varying, +
id integer NOT NULL, +
param_value numeric, +
dispersion_type character varying, +
dispersion_value numeric, +
p_value_modifier character varying, +
p_value double precision, +
ci_n_sides character varying, +
ci_percent numeric, +
ci_lower_limit numeric, +
ci_upper_limit numeric, +
ci_upper_limit_na_comment character varying, +
p_value_description character varying, +
method character varying, +
method_description text, +
estimate_description text, +
groups_description text, +
non_inferiority_description text +
); +
CREATE TABLE ctgov.outcome_analysis_groups +
( +
result_group_id integer, +
ctgov_group_code character varying, +
id integer NOT NULL, +
nct_id character varying, +
outcome_analysis_id integer +
); +
CREATE TABLE ctgov.outcome_counts +
( +
result_group_id integer, +
ctgov_group_code character varying, +
scope character varying, +
units character varying, +
count integer, +
outcome_id integer, +
nct_id character varying, +
id integer NOT NULL +
); +
CREATE TABLE ctgov.outcome_measurements +
( +
result_group_id integer, +
ctgov_group_code character varying, +
classification character varying, +
category character varying, +
title character varying, +
description text, +
units character varying, +
param_type character varying, +
param_value character varying, +
param_value_num numeric, +
dispersion_type character varying, +
dispersion_value character varying, +
dispersion_value_num numeric, +
dispersion_lower_limit numeric, +
dispersion_upper_limit numeric, +
explanation_of_na text, +
id integer NOT NULL, +
nct_id character varying, +
outcome_id integer +
); +
CREATE TABLE ctgov.outcomes +
( +
population text, +
id integer NOT NULL, +
nct_id character varying, +
outcome_type character varying, +
title text, +
description text, +
time_frame text, +
anticipated_posting_date date, +
anticipated_posting_month_year character varying, +
units character varying, +
units_analyzed character varying, +
dispersion_type character varying, +
param_type character varying +
); +
CREATE TABLE ctgov.overall_officials +
( +
name character varying, +
affiliation character varying, +
role character varying, +
nct_id character varying, +
id integer NOT NULL +
); +
CREATE TABLE ctgov.participant_flows +
( +
count_units integer, +
nct_id character varying, +
pre_assignment_details text, +
units_analyzed character varying, +
drop_withdraw_comment character varying, +
reason_comment character varying, +
recruitment_details text, +
id integer NOT NULL +
); +
CREATE TABLE ctgov.pending_results +
( +
event_date_description character varying, +
event_date date, +
id integer NOT NULL, +
nct_id character varying, +
event character varying +
); +
CREATE TABLE ctgov.provided_documents +
( +
has_sap boolean, +
id integer NOT NULL, +
nct_id character varying, +
document_type character varying, +
has_protocol boolean, +
has_icf boolean, +
document_date date, +
url character varying +
); +
CREATE TABLE ctgov.reported_event_totals +
( +
id integer NOT NULL, +
updated_at timestamp without time zone NOT NULL, +
created_at timestamp without time zone NOT NULL, +
subjects_at_risk integer, +
subjects_affected integer, +
classification character varying NOT NULL, +
event_type character varying, +
ctgov_group_code character varying NOT NULL, +
nct_id character varying NOT NULL +
); +
CREATE TABLE ctgov.reported_events +
( +
vocab character varying, +
nct_id character varying, +
result_group_id integer, +
ctgov_group_code character varying, +
time_frame text, +
event_type character varying, +
default_vocab character varying, +
default_assessment character varying, +
subjects_affected integer, +
subjects_at_risk integer, +
description text, +
event_count integer, +
organ_system character varying, +
adverse_event_term character varying, +
frequency_threshold integer, +
assessment character varying, +
id integer NOT NULL +
); +
CREATE TABLE ctgov.responsible_parties +
( +
affiliation text, +
nct_id character varying, +
responsible_party_type character varying, +
name character varying, +
title character varying, +
organization character varying, +
id integer NOT NULL, +
old_name_title character varying +
); +
CREATE TABLE ctgov.result_agreements +
( +
other_details text, +
restrictive_agreement character varying, +
restriction_type character varying, +
agreement text, +
pi_employee character varying, +
nct_id character varying, +
id integer NOT NULL +
); +
CREATE TABLE ctgov.result_contacts +
( +
id integer NOT NULL, +
organization character varying, +
name character varying, +
phone character varying, +
email character varying, +
extension character varying, +
nct_id character varying +
); +
CREATE TABLE ctgov.result_groups +
( +
result_type character varying, +
title character varying, +
description text, +
id integer NOT NULL, +
nct_id character varying, +
ctgov_group_code character varying +
); +
CREATE TABLE ctgov.retractions +
( +
pmid character varying, +
id bigint NOT NULL, +
nct_id character varying, +
source character varying, +
reference_id integer +
); +
CREATE TABLE ctgov.search_results +
( +
created_at timestamp without time zone NOT NULL, +
nct_id character varying NOT NULL, +
id integer NOT NULL, +
updated_at timestamp without time zone NOT NULL, +
grouping character varying NOT NULL, +
study_search_id integer, +
name character varying NOT NULL +
); +
CREATE TABLE ctgov.sponsors +
( +
id integer NOT NULL, +
name character varying, +
lead_or_collaborator character varying, +
agency_class character varying, +
nct_id character varying +
); +
CREATE TABLE ctgov.studies +
( +
phase character varying, +
delayed_posting character varying, +
source_class character varying, +
updated_at timestamp without time zone NOT NULL, +
created_at timestamp without time zone NOT NULL, +
plan_to_share_ipd_description character varying, +
plan_to_share_ipd character varying, +
ipd_url character varying, +
ipd_access_criteria character varying, +
ipd_time_frame character varying, +
biospec_description text, +
biospec_retention character varying, +
is_us_export boolean, +
is_ppsd boolean, +
is_unapproved_device boolean, +
is_fda_regulated_device boolean, +
is_fda_regulated_drug boolean, +
has_dmc boolean, +
expanded_access_type_treatment boolean, +
expanded_access_type_intermediate boolean, +
expanded_access_type_individual boolean, +
has_expanded_access boolean, +
why_stopped character varying, +
number_of_groups integer, +
number_of_arms integer, +
limitations_and_caveats character varying, +
source character varying, +
enrollment_type character varying, +
enrollment integer, +
expanded_access_nctid character varying, +
last_known_status character varying, +
overall_status character varying, +
official_title text, +
brief_title text, +
baseline_population text, +
acronym character varying, +
study_type character varying, +
target_duration character varying, +
results_first_submitted_date date, +
study_first_submitted_date date, +
nlm_download_date_description character varying, +
primary_completion_date date, +
nct_id character varying, +
primary_completion_date_type character varying, +
primary_completion_month_year character varying, +
completion_date date, +
completion_date_type character varying, +
completion_month_year character varying, +
verification_date date, +
verification_month_year character varying, +
start_date date, +
start_date_type character varying, +
start_month_year character varying, +
last_update_posted_date_type character varying, +
last_update_posted_date date, +
last_update_submitted_qc_date date, +
disposition_first_posted_date_type character varying,+
disposition_first_posted_date date, +
disposition_first_submitted_qc_date date, +
results_first_posted_date_type character varying, +
results_first_posted_date date, +
results_first_submitted_qc_date date, +
study_first_posted_date_type character varying, +
study_first_posted_date date, +
study_first_submitted_qc_date date, +
last_update_submitted_date date, +
disposition_first_submitted_date date, +
baseline_type_units_analyzed character varying, +
fdaaa801_violation boolean, +
expanded_access_status_for_nctid character varying +
); +
CREATE TABLE ctgov.study_records +
( +
nct_id character varying, +
sha character varying, +
created_at timestamp without time zone NOT NULL, +
updated_at timestamp without time zone NOT NULL, +
type character varying, +
content json, +
id bigint NOT NULL +
); +
CREATE TABLE ctgov.study_references +
( +
id integer NOT NULL, +
citation text, +
reference_type character varying, +
pmid character varying, +
nct_id character varying +
); +
CREATE TABLE ctgov.study_searches +
( +
query character varying NOT NULL, +
id integer NOT NULL, +
updated_at timestamp without time zone NOT NULL, +
created_at timestamp without time zone NOT NULL, +
beta_api boolean NOT NULL, +
name character varying NOT NULL, +
grouping character varying NOT NULL, +
save_tsv boolean NOT NULL +
); +
CREATE TABLE ctgov.verifiers +
( +
id bigint NOT NULL, +
created_at timestamp without time zone NOT NULL, +
source json, +
updated_at timestamp without time zone NOT NULL, +
load_event_id integer, +
last_run timestamp without time zone, +
differences json NOT NULL +
); +
CREATE TABLE history.trial_snapshots +
( +
completion_date timestamp without time zone, +
nct_id character varying(15) NOT NULL, +
version integer NOT NULL, +
submission_date timestamp without time zone, +
primary_completion_date timestamp without time zone, +
primary_completion_date_category USER-DEFINED, +
start_date timestamp without time zone, +
start_date_category USER-DEFINED, +
completion_date_category USER-DEFINED, +
overall_status USER-DEFINED, +
enrollment integer, +
enrollment_category USER-DEFINED, +
sponsor character varying, +
responsible_party character varying +
); +
CREATE TABLE http.download_status +
( +
status USER-DEFINED NOT NULL, +
nct_id character varying(15) NOT NULL, +
id integer NOT NULL, +
update_timestamp timestamp with time zone +
); +
CREATE TABLE http.responses +
( +
nct_id character varying(15), +
version_a smallint, +
version_b smallint, +
url character varying(255), +
response_code smallint, +
response_date timestamp with time zone, +
id integer NOT NULL, +
html text +
); +
CREATE TABLE rxnorm_migrated.ALLNDC_HISTORY +
( +
sab character varying(10), +
ndc11_left9 character(9) NOT NULL, +
rowid integer NOT NULL, +
ndc character(13) NOT NULL, +
suppress character(1), +
edate character(6), +
sdate character(6), +
rxcui character(16) +
); +
CREATE TABLE rxnorm_migrated.ALLRXCUI_HISTORY +
( +
tty character varying(5), +
sts character(1), +
rxindb character(1), +
indb character(1), +
rowid integer NOT NULL, +
rxcui character(16) NOT NULL, +
sab character varying(20), +
str character varying(3000), +
sdate character(6), +
edate character(6) +
); +
CREATE TABLE rxnorm_migrated.rxnorm_props +
( +
rxcui character(8) NOT NULL, +
pres smallint NOT NULL, +
propvalue1 character varying(4000) NOT NULL, +
propname character varying(30) NOT NULL +
); +
CREATE TABLE rxnorm_migrated.rxnorm_relations +
( +
tty2 character(4) NOT NULL, +
rxcui1 character(8) NOT NULL, +
tty1 character(4) NOT NULL, +
cvf character(4) NOT NULL, +
rxcui2 character(8) NOT NULL +
); +
CREATE TABLE spl.nsde +
( +
proprietary_name character varying(500), +
package_ndc character varying(50), +
application_number_or_citation character varying(25),+
package_ndc11 character varying(11), +
id integer NOT NULL, +
reactivation_date date, +
inactivation_date date, +
marketing_start_date date, +
marketing_end_date date, +
billing_unit character varying(35), +
dosage_form character varying(155), +
marketing_category character varying(160), +
product_type character varying(90) +
); +
(76 rows)

415
export/output_2025-01-06_export_data_postgres_views.sql
Unescape Escape View File

@ -1,415 +0,0 @@
?column?
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
CREATE OR REPLACE VIEW ctgov.all_browse_conditions AS SELECT browse_conditions.nct_id, +
array_to_string(array_agg(DISTINCT browse_conditions.mesh_term), '|'::text) AS names +
FROM ctgov.browse_conditions +
GROUP BY browse_conditions.nct_id;
CREATE OR REPLACE VIEW ctgov.all_browse_interventions AS SELECT browse_interventions.nct_id, +
array_to_string(array_agg(browse_interventions.mesh_term), '|'::text) AS names +
FROM ctgov.browse_interventions +
GROUP BY browse_interventions.nct_id;
CREATE OR REPLACE VIEW ctgov.all_cities AS SELECT facilities.nct_id, +
array_to_string(array_agg(DISTINCT facilities.city), '|'::text) AS names +
FROM ctgov.facilities +
GROUP BY facilities.nct_id;
CREATE OR REPLACE VIEW ctgov.all_conditions AS SELECT conditions.nct_id, +
array_to_string(array_agg(DISTINCT conditions.name), '|'::text) AS names +
FROM ctgov.conditions +
GROUP BY conditions.nct_id;
CREATE OR REPLACE VIEW ctgov.all_countries AS SELECT countries.nct_id, +
array_to_string(array_agg(DISTINCT countries.name), '|'::text) AS names +
FROM ctgov.countries +
WHERE (countries.removed IS NOT TRUE) +
GROUP BY countries.nct_id;
CREATE OR REPLACE VIEW ctgov.all_design_outcomes AS SELECT design_outcomes.nct_id, +
array_to_string(array_agg(DISTINCT design_outcomes.measure), '|'::text) AS names +
FROM ctgov.design_outcomes +
GROUP BY design_outcomes.nct_id;
CREATE OR REPLACE VIEW ctgov.all_facilities AS SELECT facilities.nct_id, +
array_to_string(array_agg(facilities.name), '|'::text) AS names +
FROM ctgov.facilities +
GROUP BY facilities.nct_id;
CREATE OR REPLACE VIEW ctgov.all_group_types AS SELECT design_groups.nct_id, +
array_to_string(array_agg(DISTINCT design_groups.group_type), '|'::text) AS names +
FROM ctgov.design_groups +
GROUP BY design_groups.nct_id;
CREATE OR REPLACE VIEW ctgov.all_id_information AS SELECT id_information.nct_id, +
array_to_string(array_agg(DISTINCT id_information.id_value), '|'::text) AS names +
FROM ctgov.id_information +
GROUP BY id_information.nct_id;
CREATE OR REPLACE VIEW ctgov.all_intervention_types AS SELECT interventions.nct_id, +
array_to_string(array_agg(interventions.intervention_type), '|'::text) AS names +
FROM ctgov.interventions +
GROUP BY interventions.nct_id;
CREATE OR REPLACE VIEW ctgov.all_interventions AS SELECT interventions.nct_id, +
array_to_string(array_agg(interventions.name), '|'::text) AS names +
FROM ctgov.interventions +
GROUP BY interventions.nct_id;
CREATE OR REPLACE VIEW ctgov.all_keywords AS SELECT keywords.nct_id, +
array_to_string(array_agg(DISTINCT keywords.name), '|'::text) AS names +
FROM ctgov.keywords +
GROUP BY keywords.nct_id;
CREATE OR REPLACE VIEW ctgov.all_overall_official_affiliations AS SELECT overall_officials.nct_id, +
array_to_string(array_agg(overall_officials.affiliation), '|'::text) AS names +
FROM ctgov.overall_officials +
GROUP BY overall_officials.nct_id;
CREATE OR REPLACE VIEW ctgov.all_overall_officials AS SELECT overall_officials.nct_id, +
array_to_string(array_agg(overall_officials.name), '|'::text) AS names +
FROM ctgov.overall_officials +
GROUP BY overall_officials.nct_id;
CREATE OR REPLACE VIEW ctgov.all_primary_outcome_measures AS SELECT design_outcomes.nct_id, +
array_to_string(array_agg(DISTINCT design_outcomes.measure), '|'::text) AS names +
FROM ctgov.design_outcomes +
WHERE ((design_outcomes.outcome_type)::text = 'primary'::text) +
GROUP BY design_outcomes.nct_id;
CREATE OR REPLACE VIEW ctgov.all_secondary_outcome_measures AS SELECT design_outcomes.nct_id, +
array_to_string(array_agg(DISTINCT design_outcomes.measure), '|'::text) AS names +
FROM ctgov.design_outcomes +
WHERE ((design_outcomes.outcome_type)::text = 'secondary'::text) +
GROUP BY design_outcomes.nct_id;
CREATE OR REPLACE VIEW ctgov.all_sponsors AS SELECT sponsors.nct_id, +
array_to_string(array_agg(DISTINCT sponsors.name), '|'::text) AS names +
FROM ctgov.sponsors +
GROUP BY sponsors.nct_id;
CREATE OR REPLACE VIEW ctgov.all_states AS SELECT facilities.nct_id, +
array_to_string(array_agg(DISTINCT facilities.state), '|'::text) AS names +
FROM ctgov.facilities +
GROUP BY facilities.nct_id;
CREATE OR REPLACE VIEW ctgov.categories AS SELECT search_results.id, +
search_results.nct_id, +
search_results.name, +
search_results.created_at, +
search_results.updated_at, +
search_results."grouping", +
search_results.study_search_id +
FROM ctgov.search_results;
CREATE OR REPLACE VIEW ctgov.covid_19_studies AS SELECT s.nct_id, +
s.overall_status, +
s.study_type, +
s.official_title, +
s.acronym, +
s.phase, +
s.why_stopped, +
s.has_dmc, +
s.enrollment, +
s.is_fda_regulated_device, +
s.is_fda_regulated_drug, +
s.is_unapproved_device, +
s.has_expanded_access, +
s.study_first_submitted_date, +
s.last_update_posted_date, +
s.results_first_posted_date, +
s.start_date, +
s.primary_completion_date, +
s.completion_date, +
s.study_first_posted_date, +
cv.number_of_facilities, +
cv.has_single_facility, +
cv.nlm_download_date, +
s.number_of_arms, +
s.number_of_groups, +
sp.name AS lead_sponsor, +
aid.names AS other_ids, +
e.gender, +
e.gender_based, +
e.gender_description, +
e.population, +
e.minimum_age, +
e.maximum_age, +
e.criteria, +
e.healthy_volunteers, +
ak.names AS keywords, +
ai.names AS interventions, +
ac.names AS conditions, +
d.primary_purpose, +
d.allocation, +
d.observational_model, +
d.intervention_model, +
d.masking, +
d.subject_masked, +
d.caregiver_masked, +
d.investigator_masked, +
d.outcomes_assessor_masked, +
ado.names AS design_outcomes, +
bs.description AS brief_summary, +
dd.description AS detailed_description +
FROM (((((((((((ctgov.studies s +
FULL JOIN ctgov.all_conditions ac ON (((s.nct_id)::text = (ac.nct_id)::text))) +
FULL JOIN ctgov.all_id_information aid ON (((s.nct_id)::text = (aid.nct_id)::text))) +
FULL JOIN ctgov.all_design_outcomes ado ON (((s.nct_id)::text = (ado.nct_id)::text))) +
FULL JOIN ctgov.all_keywords ak ON (((s.nct_id)::text = (ak.nct_id)::text))) +
FULL JOIN ctgov.all_interventions ai ON (((s.nct_id)::text = (ai.nct_id)::text))) +
FULL JOIN ctgov.sponsors sp ON (((s.nct_id)::text = (sp.nct_id)::text))) +
FULL JOIN ctgov.calculated_values cv ON (((s.nct_id)::text = (cv.nct_id)::text))) +
FULL JOIN ctgov.designs d ON (((s.nct_id)::text = (d.nct_id)::text))) +
FULL JOIN ctgov.eligibilities e ON (((s.nct_id)::text = (e.nct_id)::text))) +
FULL JOIN ctgov.brief_summaries bs ON (((s.nct_id)::text = (bs.nct_id)::text))) +
FULL JOIN ctgov.detailed_descriptions dd ON (((s.nct_id)::text = (dd.nct_id)::text))) +
WHERE (((sp.lead_or_collaborator)::text = 'lead'::text) AND ((s.nct_id)::text IN ( SELECT search_results.nct_id +
FROM ctgov.search_results +
WHERE ((search_results.name)::text = 'covid-19'::text))));
CREATE OR REPLACE VIEW history.match_drugs_to_trials AS SELECT bi.nct_id, +
rp.rxcui, +
rp.propvalue1 +
FROM (ctgov.browse_interventions bi +
JOIN rxnorm_migrated.rxnorm_props rp ON (((bi.downcase_mesh_term)::text = (rp.propvalue1)::text))) +
WHERE (((rp.propname)::text = 'RxNorm Name'::text) AND ((bi.nct_id)::text IN ( SELECT trial_snapshots.nct_id +
FROM history.trial_snapshots)));
CREATE OR REPLACE VIEW http.most_recent_download_status AS SELECT t.nct_id, +
t.status, +
t.update_timestamp +
FROM ( SELECT download_status.id, +
download_status.nct_id, +
download_status.status, +
download_status.update_timestamp, +
row_number() OVER (PARTITION BY download_status.nct_id ORDER BY download_status.update_timestamp DESC) AS rn +
FROM http.download_status) t +
WHERE (t.rn = 1) +
ORDER BY t.nct_id;
CREATE OR REPLACE VIEW public.time_between_submission_and_start_view AS SELECT s.nct_id, +
s.start_date, +
ts.version, +
ts.submission_date, +
abs(((EXTRACT(epoch FROM (ts.submission_date - (s.start_date)::timestamp without time zone)))::double precision / (((24 * 60) * 60))::double precision)) AS start_deviance +
FROM (ctgov.studies s +
JOIN history.trial_snapshots ts ON (((s.nct_id)::text = (ts.nct_id)::text))) +
WHERE ((s.nct_id)::text IN ( SELECT DISTINCT tti.nct_id +
FROM "DiseaseBurden".trial_to_icd10 tti));
CREATE OR REPLACE VIEW public.rank_proximity_to_start_time_view AS SELECT cte.nct_id, +
cte.version, +
row_number() OVER (PARTITION BY cte.nct_id ORDER BY cte.start_deviance) AS rownum, +
cte.submission_date, +
cte.start_deviance, +
cte.start_date, +
ts.primary_completion_date, +
ts.primary_completion_date_category, +
ts.overall_status, +
ts.enrollment, +
ts.enrollment_category +
FROM (time_between_submission_and_start_view cte +
JOIN history.trial_snapshots ts ON ((((cte.nct_id)::text = (ts.nct_id)::text) AND (cte.version = ts.version))));
CREATE OR REPLACE VIEW public.enrollment_closest_to_start_view AS SELECT cte2.nct_id, +
min(cte2.rownum) AS enrollment_source +
FROM rank_proximity_to_start_time_view cte2 +
WHERE (cte2.enrollment IS NOT NULL) +
GROUP BY cte2.nct_id;
CREATE OR REPLACE VIEW public.match_trials_to_bn_in AS WITH trialncts AS ( +
SELECT DISTINCT ts.nct_id +
FROM history.trial_snapshots ts +
) +
SELECT bi.nct_id, +
bi.downcase_mesh_term, +
rr.tty2, +
rr.rxcui2 AS bn_or_in_cui, +
count(*) AS count +
FROM ((ctgov.browse_interventions bi +
LEFT JOIN rxnorm_migrated.rxnorm_props rp ON (((bi.downcase_mesh_term)::text = (rp.propvalue1)::text))) +
LEFT JOIN rxnorm_migrated.rxnorm_relations rr ON ((rr.rxcui1 = rp.rxcui))) +
WHERE (((bi.nct_id)::text IN ( SELECT trialncts.nct_id +
FROM trialncts)) AND ((bi.mesh_type)::text = 'mesh-list'::text) AND ((rp.propname)::text = 'Active_ingredient_name'::text) AND (rr.tty2 = ANY (ARRAY['BN'::bpchar, 'IN'::bpchar, 'MIN'::bpchar]))) +
GROUP BY bi.nct_id, bi.downcase_mesh_term, rr.tty2, rr.rxcui2 +
ORDER BY bi.nct_id;
CREATE OR REPLACE VIEW public.match_trial_to_ndc11 AS SELECT mttbi.nct_id, +
ah.ndc, +
count(*) AS count +
FROM ((match_trials_to_bn_in mttbi +
LEFT JOIN rxnorm_migrated.rxnorm_relations rr ON ((mttbi.bn_or_in_cui = rr.rxcui1))) +
LEFT JOIN rxnorm_migrated."ALLNDC_HISTORY" ah ON ((rr.rxcui2 = ah.rxcui))) +
WHERE ((rr.tty1 = 'BN'::bpchar) AND (rr.tty2 = ANY (ARRAY['SBD'::bpchar, 'BPCK'::bpchar])) AND ((ah.sab)::text = 'RXNORM'::text)) +
GROUP BY mttbi.nct_id, ah.ndc +
ORDER BY mttbi.nct_id, ah.ndc;
CREATE OR REPLACE VIEW public.match_trial_to_marketing_start_date AS SELECT mttn.nct_id, +
n.application_number_or_citation, +
min(n.marketing_start_date) AS min +
FROM (match_trial_to_ndc11 mttn +
JOIN spl.nsde n ON ((mttn.ndc = (n.package_ndc11)::bpchar))) +
WHERE (((n.product_type)::text = 'HUMAN PRESCRIPTION DRUG'::text) AND ((n.marketing_category)::text = ANY (ARRAY[('NDA'::character varying)::text, ('ANDA'::character varying)::text, ('BLA'::character varying)::text, ('NDA authorized generic'::character varying)::text, ('NDA AUTHORIZED GENERIC'::character varying)::text]))) +
GROUP BY mttn.nct_id, n.application_number_or_citation +
ORDER BY mttn.nct_id;
CREATE OR REPLACE VIEW public.view_burdens_cte AS SELECT b.measure_id, +
b.location_id, +
b.sex_id, +
b.age_id, +
b.cause_id, +
b.metric_id, +
b.year, +
b.val, +
b.upper_95, +
b.lower_95, +
b.key_column +
FROM "DiseaseBurden".burdens b +
WHERE ((b.sex_id = 3) AND (b.metric_id = 1) AND (b.measure_id = 2) AND (b.age_id = 22));
CREATE OR REPLACE VIEW public.view_burdens_cte2 AS SELECT c1.cause_id, +
c1.year, +
c1.val AS h_sdi_val, +
c1.upper_95 AS h_sdi_u95, +
c1.lower_95 AS h_sdi_l95, +
c2.val AS hm_sdi_val, +
c2.upper_95 AS hm_sdi_u95, +
c2.lower_95 AS hm_sdi_l95, +
c3.val AS m_sdi_val, +
c3.upper_95 AS m_sdi_u95, +
c3.lower_95 AS m_sdi_l95, +
c4.val AS lm_sdi_val, +
c4.upper_95 AS lm_sdi_u95, +
c4.lower_95 AS lm_sdi_l95, +
c5.val AS l_sdi_val, +
c5.upper_95 AS l_sdi_u95, +
c5.lower_95 AS l_sdi_l95 +
FROM ((((view_burdens_cte c1 +
JOIN view_burdens_cte c2 ON (((c1.cause_id = c2.cause_id) AND (c1.year = c2.year)))) +
JOIN view_burdens_cte c3 ON (((c1.cause_id = c3.cause_id) AND (c1.year = c3.year)))) +
JOIN view_burdens_cte c4 ON (((c1.cause_id = c4.cause_id) AND (c1.year = c4.year)))) +
JOIN view_burdens_cte c5 ON (((c1.cause_id = c5.cause_id) AND (c1.year = c5.year)))) +
WHERE ((c1.location_id = 44635) AND (c2.location_id = 44634) AND (c3.location_id = 44639) AND (c4.location_id = 44636) AND (c5.location_id = 44637));
CREATE OR REPLACE VIEW public.view_cte AS SELECT ts.nct_id, +
ts.primary_completion_date, +
ts.primary_completion_date_category, +
ts.enrollment, +
ts.start_date, +
ts.enrollment_category, +
ts.overall_status, +
min(ts.submission_date) AS earliest_date_observed +
FROM history.trial_snapshots ts +
WHERE (((ts.nct_id)::text IN ( SELECT DISTINCT tti.nct_id +
FROM "DiseaseBurden".trial_to_icd10 tti +
WHERE (tti.approved = 'accepted'::"DiseaseBurden".validation_type))) AND (ts.submission_date >= ts.start_date) AND (ts.overall_status <> ALL (ARRAY['Completed'::history.study_statuses, 'Terminated'::history.study_statuses]))) +
GROUP BY ts.nct_id, ts.primary_completion_date, ts.primary_completion_date_category, ts.start_date, ts.enrollment, ts.enrollment_category, ts.overall_status;
CREATE OR REPLACE VIEW public.view_disbur_cte0 AS SELECT tti.nct_id, +
tti.ui, +
tti.condition, +
itc.cause_text, +
ch.cause_id, +
ch.level +
FROM (("DiseaseBurden".trial_to_icd10 tti +
JOIN "DiseaseBurden".icd10_to_cause itc ON ((replace(replace((tti.ui)::text, '-'::text, ''::text), '.'::text, ''::text) = replace(replace((itc.code)::text, '-'::text, ''::text), '.'::text, ''::text)))) +
JOIN "DiseaseBurden".cause_hierarchy ch ON (((itc.cause_text)::text = (ch.cause_name)::text))) +
WHERE (tti.approved = 'accepted'::"DiseaseBurden".validation_type);
CREATE OR REPLACE VIEW public.view_disbur_cte AS SELECT view_disbur_cte0.nct_id, +
max(view_disbur_cte0.level) AS max_level +
FROM view_disbur_cte0 +
GROUP BY view_disbur_cte0.nct_id;
CREATE OR REPLACE VIEW public.view_trial_to_cause AS SELECT tti.nct_id, +
tti.ui, +
tti.condition, +
itc.cause_text, +
ch.cause_id, +
ch.level +
FROM (("DiseaseBurden".trial_to_icd10 tti +
JOIN "DiseaseBurden".icd10_to_cause itc ON ((replace(replace((tti.ui)::text, '-'::text, ''::text), '.'::text, ''::text) = replace(replace((itc.code)::text, '-'::text, ''::text), '.'::text, ''::text)))) +
JOIN "DiseaseBurden".cause_hierarchy ch ON (((itc.cause_text)::text = (ch.cause_name)::text))) +
WHERE (tti.approved = 'accepted'::"DiseaseBurden".validation_type) +
ORDER BY tti.nct_id;
CREATE OR REPLACE VIEW public.view_disbur_cte2 AS SELECT ttc.nct_id, +
ttc.ui, +
ttc.condition, +
ttc.cause_text, +
ttc.cause_id, +
disbur_cte.max_level +
FROM (view_trial_to_cause ttc +
JOIN view_disbur_cte disbur_cte ON (((disbur_cte.nct_id)::text = (ttc.nct_id)::text))) +
WHERE (ttc.level = disbur_cte.max_level) +
GROUP BY ttc.nct_id, ttc.ui, ttc.condition, ttc.cause_text, ttc.cause_id, disbur_cte.max_level +
ORDER BY ttc.nct_id, ttc.ui;
CREATE OR REPLACE VIEW public.view_disbur_cte3 AS SELECT disbur_cte2.nct_id, +
SUBSTRING(disbur_cte2.ui FROM 1 FOR 3) AS code, +
disbur_cte2.condition, +
disbur_cte2.cause_text, +
disbur_cte2.cause_id, +
ic.chapter_code AS category_id, +
ic.group_name, +
disbur_cte2.max_level +
FROM (view_disbur_cte2 disbur_cte2 +
JOIN "DiseaseBurden".icd10_categories ic ON (((SUBSTRING(disbur_cte2.ui FROM 1 FOR 3) <= (ic.end_code)::text) AND (SUBSTRING(disbur_cte2.ui FROM 1 FOR 3) >= (ic.start_code)::text)))) +
WHERE (ic.level = 1);
CREATE OR REPLACE VIEW public.formatted_data AS SELECT cte.nct_id, +
cte.start_date, +
cte.enrollment AS current_enrollment, +
cte.enrollment_category, +
cte.overall_status AS current_status, +
cte.earliest_date_observed, +
(EXTRACT(epoch FROM (cte.earliest_date_observed - cte.start_date)) / EXTRACT(epoch FROM (cte.primary_completion_date - cte.start_date))) AS elapsed_duration, +
count(DISTINCT mttmsd.application_number_or_citation) AS n_brands, +
dbc3.code, +
dbc3.condition, +
dbc3.cause_text, +
dbc3.cause_id, +
dbc3.category_id, +
dbc3.group_name, +
dbc3.max_level, +
b.year, +
b.h_sdi_val, +
b.h_sdi_u95, +
b.h_sdi_l95, +
b.hm_sdi_val, +
b.hm_sdi_u95, +
b.hm_sdi_l95, +
b.m_sdi_val, +
b.m_sdi_u95, +
b.m_sdi_l95, +
b.lm_sdi_val, +
b.lm_sdi_u95, +
b.lm_sdi_l95, +
b.l_sdi_val, +
b.l_sdi_u95, +
b.l_sdi_l95 +
FROM (((view_cte cte +
JOIN match_trial_to_marketing_start_date mttmsd ON (((cte.nct_id)::text = (mttmsd.nct_id)::text))) +
JOIN view_disbur_cte3 dbc3 ON (((dbc3.nct_id)::text = (cte.nct_id)::text))) +
JOIN view_burdens_cte2 b ON (((b.cause_id = dbc3.cause_id) AND (EXTRACT(year FROM b.year) = EXTRACT(year FROM cte.earliest_date_observed))))) +
WHERE (mttmsd.min <= cte.earliest_date_observed) +
GROUP BY cte.nct_id, cte.start_date, cte.enrollment, cte.enrollment_category, cte.overall_status, cte.earliest_date_observed, (EXTRACT(epoch FROM (cte.earliest_date_observed - cte.start_date)) / EXTRACT(epoch FROM (cte.primary_completion_date - cte.start_date))), dbc3.code, dbc3.condition, dbc3.cause_text, dbc3.cause_id, dbc3.category_id, dbc3.group_name, dbc3.max_level, b.cause_id, b.year, b.h_sdi_val, b.h_sdi_u95, b.h_sdi_l95, b.hm_sdi_val, b.hm_sdi_u95, b.hm_sdi_l95, b.m_sdi_val, b.m_sdi_u95, b.m_sdi_l95, b.lm_sdi_val, b.lm_sdi_u95, b.lm_sdi_l95, b.l_sdi_val, b.l_sdi_u95, b.l_sdi_l95+
ORDER BY cte.nct_id, cte.earliest_date_observed;
CREATE OR REPLACE VIEW public.formatted_data_with_planned_enrollment AS SELECT f.nct_id, +
f.start_date, +
f.current_enrollment, +
f.enrollment_category, +
f.current_status, +
f.earliest_date_observed, +
f.elapsed_duration, +
f.n_brands, +
f.code, +
f.condition, +
f.cause_text, +
f.cause_id, +
f.category_id, +
f.group_name, +
f.max_level, +
f.year, +
f.h_sdi_val, +
f.h_sdi_u95, +
f.h_sdi_l95, +
f.hm_sdi_val, +
f.hm_sdi_u95, +
f.hm_sdi_l95, +
f.m_sdi_val, +
f.m_sdi_u95, +
f.m_sdi_l95, +
f.lm_sdi_val, +
f.lm_sdi_u95, +
f.lm_sdi_l95, +
f.l_sdi_val, +
f.l_sdi_u95, +
f.l_sdi_l95, +
s.overall_status AS final_status, +
c2a.version, +
c2a.enrollment AS planned_enrollment +
FROM (((formatted_data f +
JOIN ctgov.studies s ON (((f.nct_id)::text = (s.nct_id)::text))) +
JOIN enrollment_closest_to_start_view c3e ON (((c3e.nct_id)::text = (f.nct_id)::text))) +
JOIN rank_proximity_to_start_time_view c2a ON ((((c3e.nct_id)::text = (c2a.nct_id)::text) AND (c3e.enrollment_source = c2a.rownum))));
CREATE OR REPLACE VIEW http.trials_to_download AS SELECT most_recent_download_status.nct_id +
FROM http.most_recent_download_status +
WHERE (most_recent_download_status.status = 'Of Interest'::http.history_download_status);
CREATE OR REPLACE VIEW public.primary_design_outcomes AS SELECT do2.id, +
do2.nct_id, +
do2.outcome_type, +
do2.measure, +
do2.time_frame, +
do2.population, +
do2.description +
FROM ctgov.design_outcomes do2 +
WHERE (((do2.outcome_type)::text = 'primary'::text) AND ((do2.nct_id)::text IN ( SELECT DISTINCT fd.nct_id +
FROM formatted_data fd)));
(40 rows)

47
justfile
Unescape Escape View File

@ -5,19 +5,23 @@
# - move postgress login credentials (allow them to be printed from just while setting up) # - move postgress login credentials (allow them to be printed from just while setting up)
data_link := "https://ctti-aact.nyc3.digitaloceanspaces.com/27grtsnhtccplxapj2o8ak9aotvv" #paths for aact_db (postgres)
data_file := "2022-12-23_postgres_data.zip" aact_download_link := "https://ctti-aact.nyc3.digitaloceanspaces.com/27grtsnhtccplxapj2o8ak9aotvv"
data_path := "./containers/AACT_downloader/aact_downloads" aact_download_file := "2022-12-23_postgres_data.zip"
data_filepath := data_path / data_file aact_download_path := "./containers/AACT_downloader/aact_downloads"
aact_zipped_data_filepath := aact_download_path / aact_download_file
#must match the 'container name: aact_db' in the docker-compose.yaml #must match the 'container name: aact_db' in the docker-compose.yaml
docker_container := `docker container ls -a | grep aact_db | cut -f 1 -d " " | tr "\n" " "` docker_container := `docker container ls -a | grep "aact_db|rxnav_db" | cut -f 1 -d " " | tr "\n" " "`
#paths for rxnavinabox
rxnav_path := "./containers/RxNav-In-a-box"
rxnav_version := "rxnav-in-a-box-20230103"
rxnav_data_path := rxnav_path / rxnav_version / "mysql" / "02_data.sql"
#Various paths for docker stuff #Various paths for docker stuff
docker-compose_path := "./AACT_downloader/docker-compose.yaml" docker-compose_path := "./containers/docker-compose.yaml"
#rxnorm_mappings
rxnorm_mappings_url := "https://dailymed-data.nlm.nih.gov/public-release-files/rxnorm_mappings.zip"
#Number of historical trials to download. #Number of historical trials to download.
count := "100" count := "100"
@ -28,19 +32,24 @@ check-status:
docker --version docker --version
#check if python version > 3.10. #check if python version > 3.10.
python --version python --version
python -c 'import sys; exit(sys.hexversion >= 50859504)' #python -c 'import sys; exit(sys.hexversion >= 50859504)'
curl --version curl --version
echo "current docker containers:{{docker_container}}" echo "current docker containers:{{docker_container}}"
#Setup the AACT container
setup-containers: setup-containers:
echo "todo"
@echo "Check for downloaded data" @echo "Check for downloaded data"
[ -s {{data_path}}/postgres_data.dmp ] #aact
[ -s {{aact_download_path}}/postgres_data.dmp ]
#rxnav
[ -s {{rxnav_data_path}} ]
#run docker compose #run docker compose
@echo "Setting up AACT container" @echo "Setting up AACT_db & RxNav_db container"
docker-compose -f {{docker-compose_path}} up -d docker-compose -f {{docker-compose_path}} up -d
#Stop the appropriate docker container #Stop the appropriate docker container
stop-containers: stop-containers:
#stop all docker containers if they are currently running. #stop all docker containers if they are currently running.
@ -60,10 +69,13 @@ clean-docker: stop-containers
#Download the AACT data #Download the AACT data
download-aact-data: download-aact-data:
curl {{data_link}} > ./AACT_downloader/aact_downloads/{{data_file}} #download
unzip {{data_filepath}} -d {{data_path}} curl {{aact_download_link}} > {{aact_zipped_data_filepath}}
rm {{data_filepath}} unzip {{aact_zipped_data_filepath}} -d {{aact_download_path}}
rm {{aact_zipped_data_filepath}}
download-rxnav-data:
echo "Currently manually downloaded."
#build based on previously downloaded data #build based on previously downloaded data
build: check-status setup-containers build: check-status setup-containers
@ -105,8 +117,3 @@ get-nsde:
cd market_data && bash download_nsde.sh cd market_data && bash download_nsde.sh
cd market_data && python extract_nsde.py cd market_data && python extract_nsde.py
get-rxnorm-mappings:
#this may not be needed, all it does is match spls to rxcuis and I think I already have that.
curl {{rxnorm_mappings_url}} > ./market_data/rxnorm_mappings.zip
cd ./market_data && unzip ./rxnorm_mappings.zip
rm ./market_data/rxnorm_mappings.zip

55
llm-extractor/llm_extractor.py
Unescape Escape View File

@ -1,55 +0,0 @@
import ollama
import psycopg
from psycopg.rows import dict_row
from typing import List, Dict
def fetch_all_rows(conn_params: dict) -> List[Dict]:
# Establish a connection to the PostgreSQL database
conn = psycopg.connect(**conn_params, row_factory=dict_row)
cursor = conn.cursor()
# Define your SQL query to select all rows from the table
sql_query = "SELECT * FROM public.primary_design_outcomes;"
# Execute the query
cursor.execute(sql_query)
# Fetch all rows from the result set
rows = cursor.fetchall()
# Close the cursor and connection
cursor.close()
conn.close()
return rows
# Example usage
conn_params = {
"dbname": "aact_db",
"user": "root",
"password": "root",
"host": "localhost",
"port": "5432"
}
outcome_description = '''
Measure: {measure}
Time Frame: {time_frame}
Description: {description}
'''
if __name__ == "__main__":
#check for model
#get information
rows_dicts = fetch_all_rows(conn_params)
for row in rows_dicts[:3]:
text_data = outcome_description.format(**row)
r = ollama.generate(model='youainti/llama3.1-extractor:2024-08-28.2', prompt=text_data)
print(text_data)
print(r["response"])

31
llm-extractor/modfile_llm_extractor
Unescape Escape View File

@ -1,31 +0,0 @@
FROM llama3.1
PARAMETER num_ctx 8192
PARAMETER seed 11021585
SYSTEM """
You are a Natural Language Processor, tasked with extracting data about outcome measures from textual tables.
You are to extract the longest observation time from the primary objectives for this clinical trial.
I need you to distinguish between trials that have a specified period during which they track participants
and those trials that don't.
Return results as JSON, with the format
```json
{
"longest_observation_scalar": <number>,
"longest_observation_unit: <string: minutes, hours, days, weeks, months, years>
}
```
Do not return any other commentary.
If the study does not have a specified end of observation, set the values to `null`.
If the text does not appear to be related to clinical trials, return `{ null }`
For example:
- 'baseline to week 3' should give: `{ "longest_observation_scalar": 3, "longest_observation_unit": "weeks" }`
- 'tracked 4 months' should give: `{ "longest_observation_scalar": 4, "longest_observation_unit": "months"}`
- 'randomization to 14 months' should give `{ "longest_observation_scalar": 14, "longest_observation_unit": "months"}`
- 'After day 1 to week 48' should give `{ "longest_observation_scalar": 48, "longest_observation_unit": "weeks"}`
- 'randomization to 14 months' should give `{ "longest_observation_scalar": 14, "longest_observation_unit": "months"}`
- 'baseline until death' should give: `{ "longest_observation_scalar": null, "longest_observation_unit": null }`
- 'progression free survival up to 4 years' should give: `{ "longest_observation_scalar": null, "longest_observation_unit": null }`
- 'the quick brown fox jumped over the lazy dog for one hour' should give: `{null}`
"""

448
llm-extractor/primary_design_outcomes_202408281954.csv
Unescape Escape View File

@ -1,448 +0,0 @@
id,nct_id,outcome_type,measure,time_frame,population,description,Scalar,Unit,,,,
65857719,NCT00967798,primary,Number of Participants With Conversion to Cystic Fibrosis Related Diabetes,Month 15,,The number of participants with conversion to cystic fibrosis related diabetes was determined.,15,months,,,,
65857602,NCT00968968,primary,Progression-free Survival,"Time from randomization until disease progression or death, approximately 4 years",,"Progression-free survival (PFS) with lapatinib plus trastuzumab versus trastuzumab alone.
Progression-free survival (PFS) is defined as the time from randomization to the earliest date of disease progression (with radiological evidence) or death from any cause, or to last contact date up to 21Feb2014.
Disease Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1), a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum diameters recorded since the treatment started (the sum must have an absolute increase from nadir of 5mm), or an unequivocal progression of existing non-target lesions, or the appearance of new lesions.",??,??,,,,
66348662,NCT01067521,primary,Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression,Day 1 to 12 months,,"Relapses were monitored throughout the study. During the PC Period, two neurologists/physicians assessed subjects' general medical and neurological evaluations separately. A relapse was defined as the appearance of 1+ new neurological abnormalities or the reappearance of 1+ previously observed neurological abnormalities lasting >= 48 hours and immediately preceded by an improving neurological state of at >=30 days from onset of previous relapse. An event was counted as a relapse only when the subject's symptoms were accompanied by observed objective neurological changes, consistent with >= one of the following: - An increase of >= 0.5 in the Expanded Disability Status Scale (EDSS) score as compared to previous evaluation. - An increase of one grade in the actual score of >=2 of the 7 functional systems (FS), as compared to previous evaluation. - An increase of 2 grades in the actual score of one FS as compared to the previous evaluation. Adjusted mean values are displayed.",12,months,,,,
66348663,NCT01067521,primary,Annualized Rate of Confirmed Relapses Comparing Early Starters to Delayed Starters Estimated by Negative Binomial Regression,Day 1 up to 6.5 years,,"The annualized relapse rate (ARR) was calculated for the study by dividing the cumulative number of confirmed relapses by the number of person-years of exposure to treatment. The analysis of the annualized relapse rate is based on estimating a contrast (early start vs delayed start) derived from a baseline-adjusted, Negative Binomial Regression model to the number of confirmed relapses observed during study (post randomization) with an ""offset"" based on the log of exposure to treatment.",??,??,,,,
65846774,NCT01069705,primary,Number of Participants With Adverse Events (AEs),From time of first administration of study drug until study completion (up to 169 days),,"An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug.",??,??,,,,
65846775,NCT01069705,primary,Number of Participants With Serious Adverse Events (SAEs),From time of consent to 4 weeks after study completion (up to 199 days),,"A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.",??,??,,,,
65846776,NCT01069705,primary,Percentage of Participants With a Decrease of ≥20% in Forced Expiratory Value in One Second (FEV1) Percent (%) Predicted From Pre-dose to 30-minute Post-dose,"Pre-dose and post-dose of Day 1 and Day 29 of every Cycle (5, 6, 7)",,Airway Reactivity >= 20% relative decrease in FEV1% predicted from pre-dose to 30 minutes post-dose. Relative Change = 100 * (30 minutes Post-dose - Pre-dose)/Pre-dose assessed by the number and percentage of participants with a decrease of ≥ 20% in FEV1 % predicted from pre-dose to 30 minutes post-dose.,29,days,,,,
65846777,NCT01069705,primary,Percentage of Participants With Frequency Decrease From Baseline in the Post-baseline Audiology Tests,"Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)",,"Auditory acuity of participants was measured using a standard dual-channel audiometer at frequencies from 250 to 8000 Hertz, and an audiogram (pure-tone air conduction) and tympanogram were performed by an audiologist. The categories reported includes >= 10dB decrease in 3 consecutive frequencies in either ear, >= 15dB decrease in 2 consecutive frequencies in either ear, and >= 20dB decrease in at least one frequency in either ear",,,,,,
65846254,NCT01074047,primary,Kaplan-Meier Estimates for Overall Survival,Day 1 (randomization) to 40 months,,Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive.,,,,,,
65845812,NCT01077518,primary,Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC),From randomization to the date of first documented disease progression or death due to any cause (67.5 months),,PFS is defined as the time interval between randomization until disease progression or death (due to any cause).,,,,,,
65845533,NCT01079806,primary,Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48,At Week 48,,"Suppression=HBV DNA<50 IU/mL (approximately 300 copies/mL) using the Roche COBAS TaqMan HBV Test for use with the High Pure System assay; seroconversion=undetectable HBeAg and detectable anti-hepatitis B e antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.",,,,,,
65843612,NCT01099579,primary,"Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation",From Day 1 to Week 48,,"AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.",,,,,,
65843613,NCT01099579,primary,Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4,After Day 1 to Week 48,,"ALT=alanine aminotransferase; SGPT=serum glutamic-pyruvic transaminase; AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal. Grading by the National Institute of Health Division of AIDs and World Health Organization criteria. Hemoglobin (g/dL): Grade (Gr)1=9.5-11.0; Gr 2=8.0-9.4; Gr 3=6.5-7.9; Gr 4=<6.5. Neutrophils, absolute (/mm^3): Gr 1=>=1000-<1500; Gr 2= >=750-<1000; Gr 3=>=500-<750; Gr 4=<500. ALT/SGPT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=>10. AST/SGOT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=>10. Alkaline phosphatase(*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5: Gr 3=5.1-10; Gr 4=>10. Total bilirubin (*ULN): Gr 1=1.1-1; Gr 2=1.6-2.5; Gr 3=2.6-5; Gr 4=>5. Amylase (*ULN): Gr 1=1.10-39; Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Lipase (*ULN): Gr 1=1.10-1.39: Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12.0; Gr 3=12.1-15.0; Gr 4=>15.",,,,,,
65843614,NCT01099579,primary,"Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48",From Baseline to Week 48,,"Electrocardiogram parameters were measured at baseline for QTC Bazett, QTC Fridericia, and PR interval. The mean change from baseline at week 48 is reported by arm in milliseconds.",,,,,,
65843615,NCT01099579,primary,Number of Participants With Centers for Disease Control (CDC) Class C AIDS Events,From Day 1 to Week 48,,"CDC Class C events are AIDS-defining events that include recurrent bacterial pneumonia (>=2 episodes in 12 months); candidiasis of the bronchi, trachea, lungs, or esophagus; invasive cervical carcinoma; disseminated or extrapulmonary coccidioidomycosis; extrapulmonary cryptococcosis; chronic intestinal cryptosporidiosis (>1 month); cytomegalovirus disease; HIV-related encephalopathy; herpes simplex: chronic ulcers, or bronchitis, pneumonitis, or esophagitis; disseminated or extrapulmonary histoplasmosis; chronic intestinal isosporiasis; Kaposi sarcoma; immunoblastic or primary brain Burkitt lymphoma; mycobacterium avium complex, kansasii, or tuberculosis; mycobacterium, other species; Pneumocystis carinii pneumonia; progressive multifocal leukoencephalopathy; Salmonella septicemia; recurrent toxoplasmosis of brain; HIV wasting syndrome (involuntary weight loss >10% of baseline body weight) with chronic diarrhea or chronic weakness and documented fever for ≥1 month.",,,,,,
65843546,NCT01100502,primary,Progression-free Survival by Independent Review,Up to approximately 4 years,,"Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first",,,,,,
65842497,NCT01111539,primary,Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14),Week 8 to Week 14,,"The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change from Week 8 indicates improvement.",,,,,,
65842494,NCT01111552,primary,Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14),Week 8 to Week 14,,"The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change from Week 8 indicates improvement. Last observation carried forward (LOCF) method was used for analyses.",,,,,,
66377721,NCT01111565,primary,Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14),Week 8 to Week 14,,"The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. Last observation carried forward (LOCF) method was used for analyses.",,,,,,
65841648,NCT01120184,primary,Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment,"Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)",,"Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.",,,,,,
65841649,NCT01120184,primary,Progression-Free Survival (PFS) According to IRF Assessment,"Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)",,"Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding confidence intervals (CIs) were computed using the Brookmeyer-Crowley method.",,,,,,
65841587,NCT01120600,primary,Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24,Baseline and Month 24,,Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.,,,,,,
65841588,NCT01120600,primary,Number of Participants Who Experienced an Adverse Event (AE),Up to 24 months (plus 14 days) after first dose of study drug,,"An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.",,,,,,
65841589,NCT01120600,primary,Number of Participants Who Discontinued Treatment Due to an AE,Up to 24 months after first dose of study drug,,"An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.",,,,,,
66384256,NCT01123707,primary,"Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs), Severe (Grade 3 or Higher) TEAEs, and Discontinuations From the Trial Due to TEAEs",From first dose up to 30 days post last dose (Up to approximately 40 weeks),,"An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention. TEAE is defined as an adverse event that started after start of study drug treatment. The Common Terminology Criteria for Adverse Events v3.0 (CTCAE) was used to determine the severity wherein Grade 1=mild AE, Grade 2=moderate AE, Grade 3=severe AE, Grade 4=life-threatening or disabling AE, Grade 5=death related to AE.",,,,,,
65840407,NCT01129882,primary,Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE),Baseline to Month 97 (+/- 3 days),,"A TEAE was defined as an AE that started after start of investigational medicinal product (IMP) treatment or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of IMP. A severe AE was one that caused inability to work or perform normal daily activity.
A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.",,,,,,
65838665,NCT01148225,primary,Number of Participants With Adverse Events,Baseline to Final Visit (up to 366 weeks),,"An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset date on or after the first dose of study drug and up to 70 days after the last dose. See the Adverse Event section for details.",,,,,,
65838666,NCT01148225,primary,Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values,Baseline to Final Visit (Up to 366 weeks),,PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 ≥ Grade 3. Abbreviations used include g=grams, L=liters.,,,,,
65838667,NCT01148225,primary,Chemistry: Number of Participants With PCS Values,Baseline to Final Visit (Up to 366 weeks),,PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 ≥ Grade 3. Abbreviations include ALT/SGPT=alanine aminotransferase/serum glutamate pyruvate transaminase, AST/SGOT=aspartate aminotransferase/serum glutamate oxaloacetate transaminase, g/L=grams/liter, mmol/L=millimoles/liter, ULN=upper limit of normal.,,
65838668,NCT01148225,primary,Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit,Baseline to Final Visit (Up to 366 weeks),,Heart rate (beats per minute) was measured while the participant was sitting.,,,,,,
65838669,NCT01148225,primary,Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit,Baseline to Final Visit (Up to 366 weeks),,Respiratory rate (respirations per minute) was measured while the participant was sitting.,,,,,,
65838670,NCT01148225,primary,Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit,Baseline to Final Visit (Up to 366 weeks),,Temperature was measured while the participant was sitting.,,,,,,
65838671,NCT01148225,primary,Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit,Baseline to Final Visit (Up to 366 weeks),,Blood pressure was measured while the participant was sitting. Abbreviations used include mmHg=millimeters of mercury.,,,,,,
65832687,NCT01201356,primary,"Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death","Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years",,"Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.",,,,,,
65968081,NCT01213017,primary,the change from baseline in synovitis and bone edema RAMRIS score.,6 weeks,,,,,,,,
65831375,NCT01214421,primary,Percent Change From the Baseline in Total Kidney Volume (TKV) for Study 156-04-251 Participants Enrolled in This Study (156-08-271),Study Baseline (Prior to Day 1 in Study 156-04-251) to Month 24 in this study (Study 156-08-271),,"Total kidney volume is a measure of disease progression in the ADPKD participants. Kidney volume was assessed in T1-weighted magnetic resonance images collected at each study site and sent to a central reviewing facility. At the central reviewing facility, radiologists used proprietary software to measure the volume of both kidneys in participants continuing from previous study (156-04-251) at Month 24 of this study (156-08-271) comparing change in TKV for the early-treated (those previously treated with tolvaptan) to delayed-treated (those previously treated with placebo). The percent change in the volume of both kidneys combined was analysed using mixed-effect model repeated measures (MMRM) analysis and reported. This outcome measure was analyzed only in the participants enrolled from the previous study - 156-04-251, as pre-specified in the protocol.",,,,,,
65829319,NCT01234337,primary,Progression-free Survival (PFS) Assessed by the Independent Review Panel According to Response Evaluation Criteria for Solid Tumors (RECIST) 1.1,From randomization of the first participant until approximately 3 years or until disease radiological progression,,"PFS was defined as the time from date of randomization to disease progression, radiological or death due to any cause, whichever occurs first. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.",,,,,,
66377362,NCT01239797,primary,Median Progression Free Survival (PFS),From randomization up to 326 events (up to approximately 38 months),,Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.,,,,,,
66377363,NCT01239797,primary,Objective Response Rate (ORR),From randomization up to approximately 38 months,,"Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.",,,,,,
64468586,NCT01285557,primary,Overall Survival (OS),"From the date of randomization until disease progression or death, cut-off date: 15 August 2014 (approximately 40 months)",,OS was defined as the time from randomization to the date of death for the ITT population. Participants who did not die were censored at the date last known to be alive. Analysis was performed by using Kaplan-Meier method.,,,,,,
65818940,NCT01335698,primary,"Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder",Day one to week 300 (approximately 22-Jan-2018),,"AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.",,,,,,
65818941,NCT01335698,primary,Number of Participants Who Experienced a SAE on ATV Powder,Day one to week 300 (approximately 22-Jan-2018),,"SAE= any of the the following: is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event (defined as a medical event(s) that may not be immediately life threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the subject or may require intervention [eg, medical, surgical] to prevent one of the other serious outcomes listed in the definition above.) Examples of such events include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization",,,,,,
65818942,NCT01335698,primary,Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder,Day one to week 300 (approximately 22-Jan-2018),,"The CDC disease staging system assesses the severity of HIV disease by CD4 cell counts and by the presence of specific HIV-related conditions. CD4 counts are classified as 1: ≥500 cells/µL, 2: 200-499 cells/µL, and 3: <200 cells/µL. Children with HIV infection are also classified in each of several categories. Category N: Not symptomatic. Category A: Mildly symptomatic. Category B: Moderately symptomatic. Category C: Severely symptomatic.",,,,,,
65818943,NCT01335698,primary,Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder,Day one to week 300 (approximately 22-Jan-2018),,"Criteria of the Division of AIDS for grading the severity of adult and pediatric adverse events as follows: Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=potentially life-threatening. Neutrophils (absolute) (adult and infants >7 days): Gr 1=1.000-1300/mm^3; Gr 2=750-999 mm^3; Gr 3=500-749 mm^3; Gr 4= <500 mm^3. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase: Gr 1=1.25-2.5*upper limit of normal (ULN); Gr 2=2.6-5.0*ULN; Gr 3=5.1-10.0*ULN; Gr 4= >10.0*ULN. Bilirubin, total (adults and infants >14 days): Gr 1=1.1-1.5*ULN; Gr 2=1.6-2.5*ULN; Gr 3=2.6-5.0*ULN; Gr 4= >5.0*ULN. Lipase: Gr 1=1.1-1.5*ULN; Gr 2=1.6-3.0*ULN; Gr 3=3.1-5.0*ULN; Gr 4= >5.0*ULN. Bicarbonate, serum low: Gr 1=16.0 mEq/L-<lower limit of normal; Gr 2=11.0-15.9 mEq/L; Gr 3=8.0-10.9 mEq/L; Gr 4= <8 mEq/L. By criteria of the World Health Organization: Amylase: Gr 1=1.0-1.39*ULN; Gr 2=1.40-2.09*ULN; Gr 3.=2.10-5.0*ULN; Gr 4= >5.0*ULN.",,,,,,
65815965,NCT01368497,primary,"Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss & Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels ≤1,000 International Units (IU) Per Milliliter (mL)",End of follow-up (up to 96 weeks),,,,,,,,
65815966,NCT01368497,primary,Incidence of Adverse Events (AEs) Per Person-Year,From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks),,"The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.",,,,,,
65815967,NCT01368497,primary,Incidence of Serious Adverse Events (SAEs) Per Person-Year,From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks),,"The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.",,,,,,
65815899,NCT01369199,primary,"Proportion of Participants With HBeAg Loss (Lack of Detectable HBeAg) AND HBV DNA ≤1,000 IU/mL",End of follow-up (up to 96 weeks),,Lack of data was considered to be treatment failure.,,,,,,
65815900,NCT01369199,primary,Incidence of Adverse Events (AEs) Per Person-Year of Observation,From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks),,"The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.",,,,,,
65815901,NCT01369199,primary,Incidence of Serious Adverse Events (SAEs) Per Person-Year,From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks),,"The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.",,,,,,
64189362,NCT01400776,primary,Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit,Baseline (Day 0) to Week 12/Final Visit,,"The severity of vaginal dryness was assessed and recorded on a questionnaire by the participants using the following 4 point scale where, 0=None (The symptom is not present), 1=Mild (The symptom is present but may be intermittent; does not interfere with participants activities or lifestyle), 2=Moderate (The symptom is present. Participant is usually aware of the symptom, but activities and lifestyle are only occasionally affected), and 3=Severe (The symptom is present. Participant is usually aware and bothered by the symptom and have modified participant's activities and/or lifestyle due to the symptom. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.",,,,,,
64189363,NCT01400776,primary,Change From Baseline in Vaginal pH to Week 12/Final Visit,Baseline (Day 0) to Week 12/Final Visit,,"Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.",,,,,,
64189364,NCT01400776,primary,Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit,Baseline (Day 0) to Week 12/Final Visit,,Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.,,,,,,
64189365,NCT01400776,primary,Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit,Baseline (Day 0) to Week 12/Final Visit,,Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.,,,,,,
65812203,NCT01413178,primary,Progression-Free Survival (PFS),3 years after transplant,,Participants that are still alive and without Multiple Myeloma 3 years after Stem cell Transplantation.,,,,,,
65811960,NCT01416441,primary,"Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation",From signing of the informed consent up to 30 days after the last dose (Up to Week 52),,An Adverse Event (AE) is defined as any untoward medical occurrence in a participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. Treatment emergent adverse events (TEAE) are adverse events occurring after the onset of study drug administration.,,,,,,
65811961,NCT01416441,primary,Number of Participants With Clinically Significant Changes in Laboratory Parameter Values,Baseline to Week 52,,"The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Participants with potentially clinically significant lab values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria were reported. Any value outside the normal range was flagged for the attention of the investigator who assessed whether or not a flagged value is of clinical significance.",,,,,,
65811962,NCT01416441,primary,Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values,Baseline to Week 52,,"Incidence of clinically relevant abnormal ECG values were reported as change from Baseline in heart rate (Tachycardia - ≥15 beats per minute (bpm), Bradycardia ≤15 bpm; Rhythm (Sinus tachycardia ≥15 bpm increase, Sinus bradycardia decrease of ≥15 bpm from Baseline); Presence of - supraventricular premature beat; ventricular premature beat; supraventricular tachycardia; ventricular tachycardia; atrial fibrillation and flutter. Conduction - Presence of primary, secondary or tertiary atrioventricular block, left bundle-branch block, right bundle-branch block, pre-excitation syndrome, other intraventricular conduction blocked QRS ≥0.12 second increase of ≥0.02 second. Acute, subacute or old Infarction, Presence of myocardial ischemia, symmetrical T-wave inversion. Increase in QTc - QTc ≥450 msec ≥10% increase. Any clinically significant change from Baseline assessed by the Investigator are reported.",,,,,,
65811963,NCT01416441,primary,"Number of Participants With Emergence of Suicidal Ideation, TEAEs Related to Suicide and Suicidality and Suicide Ideation From the Potential Suicide Events Recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS)",Baseline to Week 52,,"Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale.",,,,,,
65811964,NCT01416441,primary,Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score,"Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52)",,"The AIMS Scale is an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10) are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28. A negative change from Baseline indicates improvement.",,,,,,
65811965,NCT01416441,primary,Mean Change From Baseline in Body Mass Index (BMI),"Baseline and Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)",,"The BMI kilogram/meter square (i.e. kg/m^2) was calculated from the Baseline height and the weight at the current visit using one of the following formulae, as appropriate: Weight (kg) divided by [Height (meters)]^2.",,,,,,
65811966,NCT01416441,primary,Number of Participants With Clinically Significant Changes in Vital Signs,Baseline to Week 52,,"Vital signs assessments included orthostatic (supine and standing) blood pressure (BP) measured as millimeter of mercury [mmHg]), heart rate, (measured in beats per minute [bpm]), body weight (measured in kilograms [kg]) and body temperature. Incidence of clinically relevant abnormal values in heart rate, systolic and diastolic blood pressure and weight were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant has been supine for at least 5 minutes and again after the participant has been standing for approximately 2 minutes, but not more than 3 minutes.",,,,,,
65811967,NCT01416441,primary,Mean Change From Baseline in Simpson Angus Scale (SAS) Score,"Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52)",,"The SAS is a rating scale used to measure Extrapyramidal symptoms (EPS). The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40. A negative change from Baseline indicates improvement.",,,,,,
65811968,NCT01416441,primary,Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score,"Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)",,"The BARS was an EPS rating scale. The BARS was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia). A negative change from Baseline indicates improvement.",,,,,,
65811969,NCT01416441,primary,"Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV)","Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)",,"The SNAP-IV, ADHD Inattention subscale contains 19 items, items 1 to 9 measure inattention, items 11 to 19 measure hyperactivity/impulsivity, and item 10 for inattention domain that scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 57. The negative change from Baseline indicates improvement.",,,,,,
65811970,NCT01416441,primary,Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score,"Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)",,"The CY-BOCS is used to assess characteristics of obsession and compulsion for the week prior to the interview. Nineteen items are rated in the CY-BOCS, but the total score is the sum of only items 1 to 10 (excluding items 1b and 6b). The obsession and compulsion subtotals are the sums of items 1 to 5 (excluding 1b) and 6 to 10 (excluding 6b), respectively. A missing value for any CY-BOCS item scale could result in a missing total score or obsession and compulsion subtotals of which the item scale is a component. At baseline, the full CY-BOCS interview is conducted. At all post-baseline time points, the ""Questions on Obsessions"" (items 1 to 5) and ""Questions on Compulsions"" (items 6 to 10) are reviewed and the target symptoms identified at baseline are the primary focus for rating severity. CY-BOCS total score could range from 0 to 40. Higher scores indicate worse outcome. A negative change from Baseline indicates improvement.",,,,,,
65811971,NCT01416441,primary,Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score,"Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)",,"The CDRS-R is composed of 17 interviewer-rated symptom areas: impaired schoolwork, difficulty having fun, social withdrawal, appetite disturbance, sleep disturbance, excessive fatigue, physical complaints, irritability, excessive guilt, low self-esteem, depressed feelings, morbid ideas, suicidal ideas, excessive weeping, depressed facial affect, listless speech, and hypoactivity. The CDRS-R total score is the sum of scores for the 17 symptom areas. A missing value for any CDRS-R item scale or a not rated item scale (indicated by the value of 0) could result in a missing total score. The CDRS-R total score is the sum of scores for the 17 symptom areas and could range from 17 to 113 with higher values indicating worse outcome. A negative change from Baseline indicates improvement.",,,,,,
65811972,NCT01416441,primary,Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score,"Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52)",,"The PARS has 2 sections: the symptom checklist and the severity items. The symptom checklist is used to determine the child's repertoire of symptoms during the past week. Information is elicited from the child and parent(s) and the rater then combines information from all informants using his/her best judgment. The 7-item severity list is used to determine severity of symptoms and the PARS total score. The time frame for the PARS rating is the past week. Only those symptoms endorsed for the past week are included in the symptom checklist and rated on the severity items. The PARS total severity score is the sum of items 2, 3, 5, 6, and 7. The total severity score ranges from 0 to 25, with 25 being the worst. Codes ""8"" (Not applicable) and ""9"" (Does not know) are not included in the summation (ie, equivalent to a score of 0 in the summation). A negative change from Baseline indicates improvement.",,,,,,
65811973,NCT01416441,primary,Mean Change From Baseline in Body Weight,"Baseline to Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)",,,,,,,,
65811974,NCT01416441,primary,Mean Change From Baseline in Waist Circumference,"Baseline to Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)",,"Waist circumference was recorded before a participant's meal and at approximately the same time at each visit. Measurement was accomplished by locating the upper hip bone and the top of the right iliac crest and placing the measuring tape in a horizontal plane around the abdomen at the level of the crest. Before reading the tape measure, the assessor assured that the tape was snug, but did not compress the skin, and is parallel to the floor. The measurement was made at the end of a normal exhalation.",,,,,,
65811875,NCT01418339,primary,Change From Baseline in Yale Global Tic Severity Scale (YGTSS) - Total Tic Score (TTS),Baseline to Week 8,,"The YGTSS is a semi-structured clinical interview designed to measure the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics, each including number, frequency, intensity, complexity, and interference. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The TTS ranged from 0 (none) to 50 (severe) with a higher score represent more severe symptoms (greater reduction from baseline for greater improvement). Mixed Effect Repeated Measure Model (MMRM) analysis was performed.",,,,,,
65808618,NCT01449929,primary,Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48,Week 48,,"Assessment was done using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) ""snapshot"" algorithm.This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks). Modified Intent-To-Treat Exposed (mITT-E) Population:all randomized participants who received at least one dose of investigational product",,,,,,
64189352,NCT01455597,primary,Number of Participants With Endometrial Biopsy Results at Final Visit,Final Visit (Day closest to Day 281),,"The endometrial biopsy results was categorized as: normal results categorized as atrophic/inactive or proliferative, unsatisfactory with endometrial thickness ≤4 mm and missing biopsy with endometrial thickness ≤4 mm; abnormal results categorized as polyp, hyperplasia, and carcinoma; unknown result categorized as unsatisfactory with endometrial thickness >4 mm, missing biopsy with endometrial thickness >4 mm, unsatisfactory without transvaginal ultrasonography (TVU) result and missing biopsy without TVU result. The duration of estradiol exposure was combination of studies PR-04409.3 and PR-04509.",,,,,,
64308049,NCT01459679,primary,Mean change in maximum corneal curvature (Kmax) from baseline,Month 6 or 12,,,,,,,,
65807389,NCT01461928,primary,Maintenance II: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia,"From randomization (Maintenance II) up to disease progression or death, whichever occurs first (up to approximately 24 months)",,"Progression free survival from randomization (PFSrand) is defined as the time from date of randomization to the date of first documented disease progression or death, whichever occurs first. One participant died in Induction before randomization and one participant died in Maintenance II Observation arm due to an SAE and were not considered in the analysis as no death page was completed. The Observation arm did not include one participant with AE outcome of death reported retrospectively 2 months after discontinuation from study (censored as having no event on Day 456 post-randomization).",,,,,,
65807162,NCT01463306,primary,"Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs",Baseline (Day 1) up to 13 Months,,An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly. Treatment emergent are events between first dose of study drug and up to 28 days after last dose of study drug (up to 13 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.,,
65807163,NCT01463306,primary,Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months,Baseline up to 12 Months,,"Physical examination assessed: general appearance, dermatological, head and eyes, ears, nose, mouth, and throat, pulmonary, cardiovascular, abdominal, genitourinary (optional), lymphatic, musculoskeletal/extremities. Neurological examination assessed: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation, coordination and gait. Investigator judged clinically significant change from baseline in physical and neurological examination findings.",,,,,,
65807164,NCT01463306,primary,Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities,Baseline up to 12 months,,Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) >=30 millimeter of mercury (mmHg), maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) >=20 mmHg.,,,,,
65807165,NCT01463306,primary,Number of Participants With Tanner Staging Evaluation at Baseline,Baseline (Day 1),,"Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).",,,,,,
65807166,NCT01463306,primary,Number of Participants With Tanner Staging Evaluation at Month 12,Month 12,,"Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).",,,,,,
65807167,NCT01463306,primary,Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months,Baseline up to 12 Months,,"In this outcome measure number of participants with increase and decrease of >=7% in body weight, from baseline up to 12 months are reported.",,,,,,
65807168,NCT01463306,primary,Absolute Values for Body Height at Baseline,Baseline,,,,,,,,
65807169,NCT01463306,primary,Absolute Values for Body Height at Month 12,Month 12,,,,,,,,
65807170,NCT01463306,primary,Number of Participants With Incidence of Laboratory Abnormalities,Baseline up to 12 Months,,"Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell(RBC) count: <0.8*lower limit of normal(LLN), platelet: <0.5*LLN/greater than (>)1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN/>1.5*ULN, lymphocyte, neutrophil- absolute/%:<0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte- absolute/%:>1.2*ULN; total/direct/indirect bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN/>1.2*ULN; thyroxine, thyroid stimulating hormone <0.8*LLN/>1.2*ULN; cholesterol, triglycerides:> >1.3*ULN; blood urea nitrogen, creatinine:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium: <0.9*LLN or >1.1*ULN; glucose <0.6*LLN/>1.5*ULN, creatine kinase>2.0*ULN; urine (specific gravity <1.003/>1.030, pH <4.5/>8, glucose, ketones, protein: >=1, WBC, RBC:>=20, bacteria >20, hyaline casts/casts >1); prothrombin (PT), PT international ratio>1.1*ULN.",,,,,,
65807171,NCT01463306,primary,Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters,Baseline up to 12 Months,,"Categories for which data is reported are: 1) maximum (max) PR interval increase from baseline (IFB) (millisecond [msec]) percent change (PctChg) >=25/50%; 2) maximum QRS complex increase from baseline (msec) PctChg>=50%; 3) maximum QTcB interval (Bazett's correction) increase from baseline (msec): change >=30 to <60; change >=60; 4) maximum QTcF interval (Fridericia's correction) increase from baseline (msec): change >=30 to <60; change >=60. 'PctChg>=25/50%': >= 25% increase from baseline when baseline ECG parameter is > 200 msec, and is >= 50% increase from baseline when baseline ECG parameter is non-missing and <=200 msec.",,,,,,
65807172,NCT01463306,primary,28-Days Seizure Rate at Week 1,Week 1,,"28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.",,,,,,
65807173,NCT01463306,primary,28-Days Seizure Rate at Month 1,Month 1,,"28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.",,,,,,
65807174,NCT01463306,primary,28-Days Seizure Rate at Month 2,Month 2,,"28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.",,,,,,
65807175,NCT01463306,primary,28-Days Seizure Rate at Month 4,Month 4,,"28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.",,,,,,
65807176,NCT01463306,primary,28-Days Seizure Rate at Month 6,Month 6,,"28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.",,,,,,
65807177,NCT01463306,primary,28-Days Seizure Rate at Month 9,Month 9,,"28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.",,,,,,
65807178,NCT01463306,primary,28-Days Seizure Rate at Month 12/Early Termination,Month 12/Early Termination,,"28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.",,,,,,
64308011,NCT01470131,primary,Progression Free Survival,Analysis to be conducted after a minimum of 201 events,,,,,,,,
66358803,NCT01471444,primary,Progression-Free Survival (PFS),"From day of transplant to disease of progression or death of any cause, whichever came first, assessed up to 5 years",,Number of events with progression free survival. (Progression is defined as more than 5% blast in the peripheral blood or bone marrow biopsy.) or expired from treatment related mortality post transplant.,,,,,,
66358799,NCT01510184,primary,Overall Survival (OS) for Living Participants,"From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)",,"OS was the time from randomization to death. In living participants, survival time was censored on the last date that participants were known to be alive. OS for living participant was calculated as (end of study date/last visit date - randomization date)+ 1/30.4375. Overall Survival was summarized separately for living participants as only few participants died in this study.",,,,,,
66358800,NCT01510184,primary,Overall Survival for Death,"From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)",,OS was the time from randomization to death. OS for death calculated as (date of death - randomization date)+ 1/30.4375. Overall Survival was summarized separately for participants who were died as only few participants died in this study.,,,,,,
65801015,NCT01536392,primary,Percentage of Participants With Response Rate to Anti-Emetic Therapy Days 4-7 Each Chemotherapy Cycle,"Baseline, up to 7 days post-chemotherapy, through 5 cycles of chemotherapy measured each cycle, an average of 6 weeks",,"Response defined as no emetic or retching episodes and no rescue medication use during late onset phase (4-7 days post-chemotherapy) measured each cycle. Responses tabulated to 4 items of Morisky Medication Adherence measure for each treatment group by cycle of therapy. Elements summarized of Morrow Assessment of Nausea and Emesis and for pill counts/compliance for each treatment group by cycle of therapy. Descriptive statistics summarize total scores for Osoba Module, used to measure effect of nausea and vomiting on quality of life, for each treatment group by cycle of therapy. Osoba Nausea and Emesis Module; higher scores indicate worse quality of life. Morisky Medication Adherence Scale. Higher scores indicate higher compliance. Morisky Medication Adherence Scale is Yes=0 and No=1 , zero is the lowest level of medication adherence, and 4 is the highest level of medication adherence.",,,,,,
65800672,NCT01541215,primary,Change in HbA1c (Glycosylated Haemoglobin),"Week 0, week 26",,"Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.",,,,,,
65798269,NCT01571284,primary,Number of Participants With Treatment-Emergent Adverse Events (TEAEs),Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks),,"Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. A serious AE (SAE): Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Version 4.03 was used to assess severity (Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling) of AEs.",,,,,,
65798270,NCT01571284,primary,Number of Participants With Abnormal Hematological Parameters,Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks),,"Abnormal hematological parameters included: anaemia, thrombocytopenia, leukopenia and neutropenia. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4 as per NCI CTCAE (Version 4.03), where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.",,,,,,
65798271,NCT01571284,primary,Number of Participants With International Normalized Ratio (INR),Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks),,The INR is a derived measure of the prothrombin time. The INR is the ratio of a participant's prothrombin time to a normal control sample. Normal range (without anti coagulation therapy): 0.8-1.2, Targeted range (with anti coagulation therapy) 2.0-3.0.,,,,,
65798272,NCT01571284,primary,Number of Participants With Abnormal Electrolytes Parameters,Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks),,"Abnormal electrolytes parameters included: hyponatremia, hypernatremia, hypocalcemia, hypercalcemia, hypokalemia, and hyperkalemia. Number of participants with each of these parameters were analyzed by grades ( All Grades and Grades 3-4 as per NCI CTCAE Version 4.03, where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.",,,,,,
65798273,NCT01571284,primary,Number of Participants With Abnormal Renal and Liver Function Parameters,Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks),,"Renal and liver function parameters included: creatinine, hyperbilirubinemia, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4) as per NCI CTCAE version 4.03, where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.",,,,,,
65798274,NCT01571284,primary,Creatinine Clearance of Aflibercept Plus FOLFIRI,Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks),,"Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance was calculated using the Cockroft-Gault or Modification of Diet in Renal Disease (MDRD).",,,,,,
65798275,NCT01571284,primary,Number of Participants With Other Abnormal Biochemistry Parameters,Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks),,"Other abnormal biochemistry parameters included: hypoglycemia, hyperglycemia and hypoalbuminemia. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4) as per NCI CTCAE Version 4.03, where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.",,,,,,
65798276,NCT01571284,primary,Number of Participants With Abnormal Non-Gradable Biochemistry Parameters,Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks),,"Non-gradeable biochemistry parameters included; chloride, urea, total protein, blood urea nitrogen (BUN) and lactate dehydrogenase (LDH). Number of participants with <lower limit of normal ranges (LLN) and >upper limit of normal ranges (ULN) for each of these parameters were reported.",,,,,,
65798277,NCT01571284,primary,Number of Participants With Proteinuria Events,Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks),,"Proteinuria is defined as the ratio of protein to creatinine. Number of participants with proteinuria were analyzed by grades (Grades 1, 2, 3 ,4) as per NCI CTCAE Version 4.03 where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling.",,,,,,
65798278,NCT01571284,primary,Number of Participants With Proteinuria Grade >=2,Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks),,"Proteinuria is defined as the ratio of protein to creatinine. Number of participants with proteinuria grade >=2 (graded as per NCI CTCAE Version 4.03), where Grade>=2 represents moderate to life-threatening/disabling event.",,,,,,
65798279,NCT01571284,primary,Number of Participants With Urinary Protein-Creatinine Ratio (UPCR),Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks),,Urinary protein creatinine ratio (UPCR) corresponds to the ratio of the urinary protein and urinary creatinine concentration (expressed in mg/dL). This ratio provides an accurate quantification of 24-hours urinary protein excretion. There is a high correlation between morning UPCR and 24-hour proteinuria in participants with normal or reduced renal functions. Normal ratio is < or = 1.,,,,,,
65798280,NCT01571284,primary,Number of Participants With Proteinuria (Grade>=2) Concomitant With Hematuria and /or Hypertension,Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks),,"Proteinuria is defined as the presence of excess proteins in the urine (assessed either by spot sample, dipstick/ urine protein or 24 hour urine collection). Hematuria is defined as the presence of blood in urine (positive dipstick for RBC or reported AE). Number of participants with proteinuria grade >=2 (graded as per NCI CTCAE Version 4.03), where Grade>=2 represents moderate to life-threatening/disabling event. Hypertension (high blood pressure) is defined as having a blood pressure reading of more than 140/90 mmHg over a number of weeks.",,,,,,
65798281,NCT01571284,primary,Number of Participants With Cycle Delay and/or Dose Modification,Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks),,A theoretical cycle is a 2 week period i.e. 14 days. A cycle is delayed if duration of previous cycle is greater than 14+2 days , dose modification includes dose reduction and dose omission.,,,,,
65798168,NCT01571362,primary,Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12),Weeks 11 and 12,,Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.,,,,,,
65798111,NCT01572038,primary,"Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.",,,,,,
65798100,NCT01572038,primary,"Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0)","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. TEAEs of special interest included LVEF decreased, liver enzymes increased, and suspected transmission of infectious agent by the study drug.",,,,,,
65798101,NCT01572038,primary,Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term),The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.,,"All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal",,,,,,
65798102,NCT01572038,primary,Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term),The median (full range) duration of follow-up was 68.73 (0.03-87.29) months.,,"All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal",,,,,,
65798103,NCT01572038,primary,"Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs by system organ class (SOC) and preferred term (PT); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. If a participant experienced the same AE at more than one severity grade, only the most severe grade was presented.",,,,,,
65798104,NCT01572038,primary,"Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the system organ classes are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category.",,,,,,
65798105,NCT01572038,primary,"Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category.",,,,,,
65798106,NCT01572038,primary,"Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Discont. = discontinuation; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab",,,,,,
65798107,NCT01572038,primary,"Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Interrupt. = interruption; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab",,,,,,
65798108,NCT01572038,primary,"Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in ≥5% of Participants by Category","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; AEs may fall within multiple categories.",,,,,,
65798109,NCT01572038,primary,"Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table.",,,,,,
65798110,NCT01572038,primary,Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term,"From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs of special interest included LVEF decreased, liver enzymes (ALT or AST) increased, and suspected transmission of infectious agent by the study drug. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table. If a participant experienced more than one event in a category, they were counted only once in that category.",,,,,,
65798112,NCT01572038,primary,"Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent.",,,,,,
65798113,NCT01572038,primary,"Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent.",,,,,,
65798114,NCT01572038,primary,"Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.",,,,,,
65798115,NCT01572038,primary,"Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.",,,,,,
65798116,NCT01572038,primary,"Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.",,,,,,
65798117,NCT01572038,primary,"Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.",,,,,,
65798118,NCT01572038,primary,"Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab","From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.",,,,,,
65798119,NCT01572038,primary,Number of Participants With a Congestive Heart Failure Event,From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.,,"Congestive heart failure was defined as the Standardised MedDRA Query (SMQ) 'Cardiac failure (wide)' from the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1).",,,,,,
65798120,NCT01572038,primary,Time to Onset of the First Episode of Congestive Heart Failure,From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.,,Congestive heart failure was defined as SMQ 'Cardiac failure (wide)' from the MedDRA version 22.1. Time to onset of the first episode of congestive heart failure was analyzed using a Kaplan-Meier approach. Participants who did not experience any congestive heart failure at the time of data-cut were censored at the date of the last attended visit whilst on-treatment (including visits up to and including 28 days after last dose of study treatment). Only treatment emergent congestive heart failure events are included.,,,,,,
65798121,NCT01572038,primary,Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study,"Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,"All participants must have had a baseline LVEF ≥50% to enroll in the study; patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The change from baseline LVEF values were reported at every 3 cycles over the course of the study and at the final treatment, worst treatment, and maximum decrease values. The final treatment value was defined as the last LVEF value observed before all study treatment discontinuation. The worst treatment value was defined as the lowest LVEF value observed before all study treatment discontinuation. The maximum decrease value was defined as the largest decrease of LVEF value from baseline, or minimum increase if a participant's post-baseline LVEF measures were all larger than the baseline value.",,,,,,
65798122,NCT01572038,primary,Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study,"Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.",,All participants must have had a baseline LVEF greater than or equal to (≥)50% to enroll in the study, patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The number of participants are reported according to four change from baseline in LVEF value categories over the course of the study: 1) an increase or decrease from baseline LVEF less than (<)10% points or no change in LVEF, 2) an absolute LVEF value <45% points and a decrease from baseline LVEF ≥10% points to <15% points, 3) an absolute LVEF value <45% points and a decrease from baseline LVEF ≥15% points, or 4) an absolute LVEF value ≥45% points and a decrease from baseline LVEF ≥10% points. BL = baseline, Decr. = decrease, Incr. = increase
65798123,NCT01572038,primary,Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0,Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.,,"Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.",,,,,,
65798124,NCT01572038,primary,Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria,Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.,,"Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.",,,,,,
65798125,NCT01572038,primary,Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0,Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.,,"Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.",,,,,,
65798126,NCT01572038,primary,Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria,Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months.,,"Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.",,,,,,
65797515,NCT01578499,primary,Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4),"Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months)",,"ORR4 was determined by an Independent Review Facility (IRF) based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic assessment by an IRF and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Participants whose first response occurred after the start of subsequent anticancer therapy were excluded. Response Criteria was based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and Cutaneous Lymphoma Task Force (CLTF) of the European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines (Olsen, 2011).",,,,,,
65795896,NCT01597908,primary,Overall Survival (OS),From the date of randomization until date of death due to any cause (up to approximately 6 years),,"Overall Survival (OS) was defined as the interval of time between the date of randomization and the date of death due to any cause. For patients who did not die, OS was censored at the date of last contact.",,,,,,
65794590,NCT01610284,primary,"Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort","Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to approximately 4 years",,"Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm.",,,,,,
65792502,NCT01633060,primary,Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS),Every 6 weeks after randomization up to a maximum of 4 years,,"Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm. Patients were followed up for approximately every 6 weeks after randomization.",,,,,,
65791562,NCT01642004,primary,Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint,"Randomization until 199 deaths, up to November 2014, approximately 25 months",,"OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.",,,,,,
65791563,NCT01642004,primary,Overall Survival (OS) Rate in All Randomized Participants,"Randomization to 18 months post-randomization, up to June 2015",,"The overall survival rate is the probability that a participant will be alive at 6, 12, and 18 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.",,,,,,
65791564,NCT01642004,primary,Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint,"Randomization until 199 deaths, up to November 2014, approximately 25 months",,"The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.",,,,,,
65791148,NCT01646021,primary,Progression Free Survival (PFS),"Time from the date of randomization until the date of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death, whichever occurred first (approximately 48 months)",,"PFS is defined as the duration in months from the date of randomization to the date of progression disease (PD) or relapse from complete response (CR) or death whichever was reported first and was assessed based on the investigator assessment. Revised Response Criteria for Malignant Lymphoma categorizes the response of the treatment of a patient's tumour to CR (the disappearance of all evidence of disease), Relapsed Disease or PD (Any new lesion or increase by greater than or equal to [>=] 50 percent [%] of previously involved sites from nadir).",,,,,,
65789596,NCT01663623,primary,Time to First Relapse,Approximately up to 4 years,,Time to relapse is defined as the number of days from Day 0 until the participant experienced a relapse (relapse date - treatment start date +1). Only post-baseline relapses were considered in these analyses. Only relapses occurring up to and including the last visit date in the double-blind treatment period were considered in these analyses. Intent-to-treat population comprised of all randomized participants who received at least one dose of study agent (belimumab or placebo). NA indicates that the data was not available as the Number of events is too low to estimate the value. Median and Inter-quartile range were presented and were based on Kaplan Meier estimates.,,,,,,
64158296,NCT01673867,primary,Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint,"Randomization until 413 deaths, up to March 2015 (approximately 29 months)",,"OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.",,,,,,
64158297,NCT01673867,primary,One-year Overall Survival (OS) Rate in All Randomized Participants,12 months,,"The one-year overall survival rate is a percentage, representing the fraction of all randomized participants who were alive following one year of treatment. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.",,,,,,
64158298,NCT01673867,primary,Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint,"Randomization until 413 deaths, up to March 2015 (approximately 29 months)",,"The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.",,,,,,
65784565,NCT01713946,primary,Core Phase: European Medicine Agency (EMA): Seizure Frequency Response Rate,"Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)",,"Comparison of response rates in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm. Response means at least a 50% reduction from baseline in partial-onset seizure frequency during the maintenance period of the core phase.",,,,,,
65784566,NCT01713946,primary,Core Phase: Food & Drug Administration (FDA): Percentage Change From Baseline in Partial Onset-seizure Frequency,"Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase)",,"Comparison of median percent change from baseline in weekly seizure frequency in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during maintenance period of the core phase. Percentage change from baseline in average weekly seizure frequency during the maintenance period of the Core phase (SFcfb) = 100 × (SFB - SFM) ÷ SFB where:
SFB is the average weekly seizure frequency in the Baseline phase SFM is the average weekly seizure frequency in the maintenance period of the Core phase A positive percentage change from baseline (SFcfb) means a reduction in seizure frequency whereas a negative percentage change from baseline (SFcfb) means an increase in seizure frequency.",,,,,,
65783857,NCT01721772,primary,Overall Survival (OS),"From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months.",,OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.,,,,,,
65783858,NCT01721772,primary,Overall Survival (OS) Rate,From randomization to 6 months and or to 12 months,,OS rate is calculated as the percentage of participants alive at the indicated timepoints,,,,,,
65782873,NCT01732913,primary,Progression Free Survival,,,Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).,,,,,,
65782868,NCT01732926,primary,Progression-free Survival (PFS),,,PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).,,,,,,
65781700,NCT01747915,primary,Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase,Day 1 up to Week 12,,"All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible ""0"" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).",,,,,,
65780474,NCT01764841,primary,Time to First Exacerbation Event Within 48 Weeks,Up to Week 48,,Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.,,,,,,
65776795,NCT01808118,primary,Number of Participants Who Did Not Experience a Flare During Period 2 by Week 68,From Week 28 through 68,,"The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.",,,,,,
65776714,NCT01808573,primary,Centrally Assessed Progression Free Survival,"From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut.",,"Progression Free Survival (PFS), Measured in Months, for Randomized Subjects of the Central Assessment. The time interval from the date of randomization until the first date on which recurrence, progression (per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1), or death due to any cause, is documented. For subjects without recurrence, progression or death, it is censored at the last valid tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 24 months.",,,,,,
65776715,NCT01808573,primary,Overall Survival,"From randomization date to death, assessed up to 59 months.The result is based on primary analysis data cut.",,"Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 48 months.",,,,,,
65775940,NCT01819129,primary,Change From Baseline in HbA1c,"Week 0, Week 26",,"The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.",,,,,,
65772551,NCT01866319,primary,Progression-free Survival (PFS) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Radiology Plus Oncology Review (IRO),Up to approximately 12 months (through first pre-specified statistical analysis cut-off date of 03-Sep-2014),,"PFS was defined as the time from randomization to the first documented disease progression, based on blinded Independent Radiology plus Oncology review (IRO) using RECIST 1.1, or death due to any cause, whichever occurred first. Disease progression was defined as a 20% or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of new lesions. The primary analysis of PFS was performed at the time of the first protocol pre-specified statistical analysis, with data cut-off of 03-Sep-2014.",,,,,,
65772552,NCT01866319,primary,Percentage of Participants With Overall Survival (OS) at 12 Months,Month 12,,"OS was defined as the time from randomization to death due to any cause. The percentage of participants with OS (OS rate) at 12 months was reported for each arm. The reported percentage was estimated using a product-limit (Kaplan-Meier) method for censored data; data were censored at the date of cut-off. The primary analysis of OS was performed at the time of the second protocol pre-specified statistical analysis, with data cut-off of 03-Mar-2015.",,,,,,
65770619,NCT01891890,primary,Conners' Continuous Performance Test II (CPT-II) Confidence Index,"Baseline, Month 6",,"The Conners' Continuous Performance Test II (CPT-II) is a measure of sustained attention. Letters are individually presented on a computer screen, and participants are instructed to press the space bar when they are presented with any letter except the letter ""X"". For children younger than 6 years of age at enrollment, the Kiddie CPT will be used in which the child is instructed to press the space bar every time the ball appears on the screen. The outcome measure is a confidence index representing the probability that the respondent has a clinically relevant problem in sustained attention. Possible scores range from 0 to 100. Scores between 40 and 60 are considered inconclusive while scores above 60 indicate that the child exhibits inattentiveness.",,,,,,
65769554,NCT01905592,primary,Progression Free Survival (PFS) - Central Review Assessment,"From the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier, up to 4 years",,"The primary objective of this study is to compare progression-free survival (PFS), as assessed by blinded central review, of participants with advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative gBRCA mutation breast cancer when treated with niraparib as compared to those treated with physician's choice single agent chemotherapy standards (eribulin, vinorelbine, gemcitabine or capecitabine). PFS is defined as the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier as per Response evaluation criteria in solid tumors (RECIST) version (v)1.1 as determined by central review assessment. Progressive Disease is defined as at least a 20 percent (%) increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of >= 5 millimeter (mm).",,,,,,
65769319,NCT01908829,primary,Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours,Baseline and end of treatment (up to 12 weeks),,"The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary & at least 1 micturition postbaseline & reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable.",,,,,,
65768317,NCT01920477,primary,Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy,Baseline up to approximately 60 weeks,,Sustained remission = time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to <=10 mg/day and maintenance of a dose <=10 mg/day with no new or nonhealing lesions for >=8 weeks and maintenance of the status until Week 60.,,,,,,
65768318,NCT01920477,primary,Duration of Remission on Minimal Steroid Therapy,Baseline up to approximately 60 weeks,,Sum of all periods of absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of <=10 mg/day up to Week 60 was assessed.,,,,,,
65768118,NCT01922011,primary,"Percentage of Participants With Clinical Improvement in the 3 General Categories of Pain, Inflammation, and Limb Function Based on the Investigator's Overall Assessment of Severity of Each of the Symptom Categories.",Up to study Day 5,,"Clinical improvement was based on the Investigator's overall assessment of severity of each of the 3 general symptom categories of Pain, Inflammation, and Limb Function. Based on this evaluation, a participant was considered to have met criteria for clinical improvement according to the following definition: If 3 general categories are present at baseline: at least a 1-point improvement (i.e. severe to moderate, moderate to mild, mild to absent) in at least 2 of the general categories and no worsening in the other. If 2 general categories are present at baseline: at least a 2-point improvement (i.e. severe to mild, moderate to absent) in at least 1 of the general categories and no worsening or new findings in the others OR at least a 1-point improvement in both and no new findings in the other. If 1 general category is present at baseline: at least a 2-point improvement (i.e., severe to mild, moderate to absent) in that category and no new findings in the others.",,,,,,
65765979,NCT01940497,primary,Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs),Day 1 up to 28 days after last dose of trastuzumab (up to approximately 1 year),,An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were the AEs occurring from starting on the day of or after first administration of trastuzumab and within 28 days after last dose of trastuzumab. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.,,,,,,
65764383,NCT01958671,primary,Change From Baseline In A1C at Week 26,Baseline and Week 26,,A1C is measured as percent. The change from baseline is the Week 26 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.,,,,,,
65764384,NCT01958671,primary,Percentage of Participants Experiencing An Adverse Event (AE),Up to 54 weeks (including 2 weeks following last dose),,An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.,,,,,,
65764385,NCT01958671,primary,Percentage of Participants Discontinuing Study Treatment Due to an AE,Up to 52 weeks,,An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.,,,,,,
65764000,NCT01962441,primary,Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12),Posttreatment Week 12,,"SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.",,,,,,
65764001,NCT01962441,primary,Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event,Up to 24 weeks,,,,,,,,
65763600,NCT01967940,primary,Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10,Day 10,,,,,,,,
65762716,NCT01976364,primary,Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs),Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study),,An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 48 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.,,
65762717,NCT01976364,primary,Number of Adverse Events (AEs) by Severity,Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study),,"An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified into 3 categories according to their severity as mild AEs (did not interfere with participant's usual function), moderate AEs (interfered to some extent with participant's usual function) and severe AEs (interfered significantly with participant's usual function).",,,,,,
65762718,NCT01976364,primary,Number of Participants With Abnormal Clinical Laboratory Values,Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study),,"Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes,neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin [total, direct, indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids (cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy (urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Laboratory abnormality: determined by investigator per pre-defined criteria.",,,,,,
65762719,NCT01976364,primary,Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values,Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study),,"Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin[total,direct,indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids(cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine-pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy(urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Clinically significant change: determined by investigator per pre-defined criteria.",,,,,,
65762720,NCT01976364,primary,Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6,"Sub-study: Baseline (Day 1), Month 6",,"HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score ranged from 0 (least difficulty) to 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.",,,,,,
65762721,NCT01976364,primary,Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6,"Sub-study: Baseline (Day 1), Month 6",,"PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in millimeter (mm), swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), short form-36 questionnaire (SF-36) physical component summary (norm-based domain scores were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.",,,,,,
65761723,NCT01987479,primary,Percentage of Participants With Adverse Events,Baseline up to Week 32,,An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events included serious as well as non-serious adverse events.,,,,,,
65761714,NCT01987505,primary,Percentage of Participants With Administration-Associated Reactions (AARs),From start of treatment to end of treatment (up to 32 months),,"AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.",,,,,,
65760039,NCT02008227,primary,Percentage of Participants Who Died: PP-ITT,Baseline until death due to any cause (up to approximately 2.25 years),,,,,,,,
65760040,NCT02008227,primary,Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP,Baseline until death due to any cause (up to approximately 2.25 years),,"Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in >/=1% and <5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in >/=5% and <50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in >/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=1% and <5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=5% and <10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering >/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma.",,,,,,
65760041,NCT02008227,primary,Overall Survival (OS): PP-ITT,Baseline until death due to any cause (up to approximately 2.25 years),,OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.,,,,,,
65760042,NCT02008227,primary,OS: TC1/2/3 or IC1/2/3 Subgroup of PP,Baseline until death due to any cause (up to approximately 2.25 years),,OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.,,,,,,
65760043,NCT02008227,primary,OS: SP-ITT,Baseline until death due to any cause (up to approximately 2.87 years),,OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.,,,,,,
65760044,NCT02008227,primary,OS: TC1/2/3 Or IC1/2/3 Subgroup of SP,Baseline until death from any cause (approximately 2.87 years),,OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.,,,,,,
65760045,NCT02008227,primary,OS: TC2/3 or IC2/3 Subgroup of SP,Baseline until death due to any cause (up to approximately 2.87 years),,OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.,,,,,,
65760046,NCT02008227,primary,OS: TC3 or IC3 Subgroup of SP,Baseline until death due to any cause (up to approximately 2.87 years),,OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.,,,,,,
65759081,NCT02019420,primary,Number of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population,Up to 28 days,,The numbers of participants with all-cause mortality within 28 days after randomization was determined in the ITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.,,,,,,
64619564,NCT02032277,primary,Pathological Complete Response (pCR).,At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug).,,Pathological complete response (pCR) in the breast tissue and the lymph node tissue will be assessed upon completion of pre-operative systemic therapy and definitive surgery.,,,,,,
65757541,NCT02038920,primary,Induction Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response,Week 10,,"A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.",,,,,,
65757542,NCT02038920,primary,Maintenance Phase: Percentage of Participants With Clinical Remission,Week 60,,Clinical remission is defined as the CDAI score ≤150. CDAI is scoring system for the assessment of Crohn's disease activity. Index values of 150 and below are associated with quiescent disease, values above that indicate active disease.,,,,,
65757543,NCT02038920,primary,Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs),From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks),,"An Adverse event (AE) is defined as any untoward medical occurrence in a study participant who received a drug (including a study drug); it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.",,,,,,
65757544,NCT02038920,primary,Number of Participants With TEAE Related to Body Weight (Weight Decreased),From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks),,"Reported events on this outcome measure were ""Weight Decreased"".",,,,,,
65757545,NCT02038920,primary,Number of Participants With TEAE Related to Vital Signs,From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks),,"Vital signs included body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). Reported events on this outcome measure were ""Pyrexia"", ""Body temperature increased"", ""Hypertension"", and ""Orthostatic hypotension"".",,,,,,
65757546,NCT02038920,primary,Number of Participants With TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right],From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks),,"Reported events on this outcome measure were ""Bundle Branch Block Right"".",,,,,,
65757547,NCT02038920,primary,Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values,From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks),,"The laboratory values outside the range (Hemoglobin <=7 g/dL, Lymphocytes <500 /microL, White Blood Cell (WBC) <2000 /microL, Platelets <7.5 10^4/microL, Neutrophils <1000 /microL, Alanine Aminotransferase (ALT) (Glutamic Pyruvic Transaminase; GPT) >3.0 U/L x upper limit of normal (ULN), Aspartate Aminotransferase (AST) (Glutamic Oxaloacetic Transaminase; GOT) >3.0 U/L x ULN, Total Bilirubin >2.0 mg/dL x ULN, Amylase >2.0 (U/L) x ULN are considered markedly abnormal.",,,,,,
65757473,NCT02039505,primary,Percentage of Participants With a Clinical Response at Week 10 in Induction Phase,Week 10,,"Clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores (rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment), a global assessment by the physician, and an endoscopic subscore. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).",,,,,,
65757474,NCT02039505,primary,Percentage of Participants With Clinical Remission at Week 60 in Maintenance Phase,Week 60,,"Clinical Remission is defined as a complete Mayo score of ≤2 points and no individual subscore >1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).",,,,,,
65757475,NCT02039505,primary,Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs),From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks),,"An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.",,,,,,
65757476,NCT02039505,primary,Number of Participants With TEAE Related to Body Weight,From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks),,,,,,,,
65757477,NCT02039505,primary,Number of Participants With TEAE Related to Vital Signs,From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks),,"Vital signs included body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).",,,,,,
65757478,NCT02039505,primary,Number of Participants With TEAE Related to Electrocardiogram (ECG),From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks),,,,,,,,
65757479,NCT02039505,primary,Number of Participants With Markedly Abnormal Laboratory Parameters Values,From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks),,"The laboratory values outside the range (Hemoglobin <=7 g/dL, Lymphocytes <500 /µL, WBC <2000 /µL, Platelets <7.5 10^4/µL, Neutrophils <1000 /µL, alanine aminotransferase (ALT) >3.0 U/L x upper limit of normal (ULN), aspartate aminotransferase (AST) >3.0 U/L x ULN, Total Bilirubin >2.0 mg/dL x ULN, Amylase >2.0 (U/L) x ULN were considered markedly abnormal. Only laboratory parameters with events were represented.",,,,,,
65757314,NCT02042183,primary,Number of Participants Classified as Overall Responders at Week 12,at Week 12,,"An overall responder is defined as a participant who qualified as a weekly responder for 9 of the 12 treatment weeks, with durability demonstrated by at least 3 of the responder weeks occurring during the last 4 weeks of the treatment period. A weekly responder is defined as a participant who has at least 3 spontaneous bowel movements during the week, and at least one more than at baseline.",,,,,,
65756716,NCT02052310,primary,"US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population)","Baseline (Day 1, Week 0), Week 28 to 52",,"Hb values under the influence of rescue therapy were not censored for the primary analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (erythropoiesis-stimulating agent [ESA]) or red blood cell (RBC) transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model, Monotone missing data were imputed by regression from its own treatment group.",,,,,,
65756717,NCT02052310,primary,"Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (PPS Population)","Baseline (Day 1, Week 0) up to Week 24",,"Hb response was defined, using central laboratory values, as: Hb ≥11.0 g/dL and a Hb increase from baseline by ≥1.0 g/dL in participants whose baseline Hb >8.0 g/dL, or increase in Hb ≥2.0 g/dL in participants whose baseline Hb ≤8.0 g/dL. Rescue therapy for roxadustat treated participant was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion.",,,,,,
65755648,NCT02065557,primary,Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period,Week 8,,"The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 sub scores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in PMS indicates improvement. Clinical remission was defined as a PMS ≤ 2 and no individual subscore > 1.",,,,,,
65755649,NCT02065557,primary,Co-Primary Endpoint 2: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 52 in Week 8 Responders Per PMS - Maintenance Period,Week 52,,"The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.",,,,,,
65755630,NCT02065570,primary,Percentage of Participants Who Achieved Clinical Remission at Week 4,Week 4,,"Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.",,,,,,
65755631,NCT02065570,primary,Percentage of Participants With Endoscopic Response at Week 12,Week 12,,"Endoscopic response was scored using the Simplified Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD total score > 50% from Baseline (or for a Baseline SES-CD of 4, at least a 2 point reduction from Baseline) at Week 12.",,,,,,
65755632,NCT02065570,primary,Number of Participants With Treatment-Emergent Adverse Events (TEAEs),From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).,,"Adverse event (AE): any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. Serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. TEAEs: any event that began or worsened in severity after the first dose of study drug in the induction or maintenance study. Events with unknown severity were counted as severe. Events with unknown relationship to study drug were counted as drug-related.",,,,,,
65755607,NCT02065622,primary,Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8,Week 8,,"The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.",,,,,,
65755608,NCT02065622,primary,Maintenance Period Primary Endpoint: Percentage of Week 8 Responders (Per FMS) With Clinical Remission (Per FMS) at Week 52,Week 52,,"The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per FMS) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease from baseline in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.",,,,,,
66112997,NCT02066636,primary,The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5),From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months),,"A treatment related adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that has a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.",,,,,,
65755285,NCT02070757,primary,Percentage of Participants With All Cause Mortality in the Intent-to-Treat (ITT) Population - Day 28,Day 28,,"To demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in stratified adult participants with ventilated nosocomial pneumonia (VNP) (participants with either ventilator-associated bacterial pneumonia [VABP] or ventilated hospital-acquired bacterial pneumonia [HABP]) based on the difference in all-cause mortality rates in the intent to treat (ITT) population using a non-inferiority margin of 10%. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.",,,,,,
65755116,NCT02072824,primary,Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase,Day 1 up to Day 14,,"All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible ""0"" seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1).",,,,,,
65755005,NCT02074982,primary,Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16,Week 16,,"Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16",,,,,,
65753127,NCT02099110,primary,Change From Baseline in A1C at Week 26: Excluding Rescue Approach,Baseline and Week 26,,"A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.",,,,,,
65753128,NCT02099110,primary,Percentage of Participants Who Experienced an Adverse Event (AE): Including Rescue Approach,Up to 54 weeks,,"An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy.",,,,,,
65753129,NCT02099110,primary,Percentage of Participants Who Discontinued Study Treatment Due to an AE: Including Rescue Approach,Up to 52 weeks,,"An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy.",,,,,,
65752712,NCT02105636,primary,Overall Survival (OS),From date of randomization to date of death (Up to approximately 18 months),,OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method.,,,,,,
64619059,NCT02106546,primary,Overall Survival (OS) in current smokers,Up to 3 years from first dose of study drug,,Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.,,,,,,
65752557,NCT02106832,primary,Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo,Up to Week 48,,Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.,,,,,,
65752558,NCT02106832,primary,Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo,Up to Week 48,,Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.,,,,,,
65750571,NCT02130557,primary,Percentage of Participants With Major Molecular Response (MMR) at Month 12,Month 12,,MMR was defined as a ratio of breakpoint cluster region to abelson (BCR-ABL/ABL) less than or equal to (<=) 0.1 percent (%) on the international scale (IS) (greater than or equal to [>=] 3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts [>=3000 ABL required]) by quantitative reverse transcriptase polymerase chain reaction (RT-qPCR). The percentage of participants with MMR at Month 12 are reported.,,,,,,
65750511,NCT02131233,primary,Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48,Week 48,,"From blood samples collected at week 48, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA ""snapshot"" approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason.",,,,,,
66342088,NCT02136069,primary,"Percentage of Participants With Both Clinical Response at Week 10 and Clinical Remission at Week 54, as Determined by the Mayo Clinic Score (MCS)","Week 10, Week 54",,"Mayo Clinic Score (MCS) is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.
Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1.
Clinical Remission is MCS ≤2 with individual subscores ≤1.",,,,,,
65750053,NCT02138136,primary,Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month,within 9 months,,Spontaneous bowel movements are defined as bowel movements without the aid of drugs.,,,,,,
64198800,NCT02142738,primary,Progression Free Survival (PFS) Rate at Month 6,Month 6,,"PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment. The data cutoff was 09-May-2016. The PFS rate at Month 6 was calculated.",,,,,,
65749378,NCT02147158,primary,Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1,Last 35 consecutive days on treatment in the 12-Week Treatment Course 1,,"Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 1.",,,,,,
65749379,NCT02147158,primary,Time to Absence of Bleeding on Treatment During Treatment Course 1,From first dose up to the end of the 12-Week Treatment Course 1,,Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the first treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 1.,,,,,,
66358764,NCT02149121,primary,Analysis of Serum AUC0-last of Rituximab During the 1st Course of the Main Study Period (Over the First 24 Weeks) (ANCOVA),over the first 24 weeks,,"For evaluation of pharmacokinetics (PK), the primary endpoint was defined as the analysis of serum AUC0-last, AUC0-inf and Cmax of rituximab during the 1st course of the Main Study Period (over the first 24 weeks). During the 1st course of the Main Study Period, blood samples for PK analysis were collected every week from Week 0 to Week 4, every 4 weeks from Week 4 to Week 16, followed by Week 24.
AUC0-last: Area under the concentration-time curve from time to the last measurable concentration over both doses of the 1st course",,,,,,
66358765,NCT02149121,primary,Analysis of Serum AUC0-inf of Rituximab During the 1st Course of the Main Study Period (Over the First 24 Weeks) (ANCOVA),at Week 24 of the Main Study Period,,"For evaluation of PK, the primary endpoint was defined as the analysis of serum AUC0-last, AUC0-inf and Cmax of rituximab during the 1st course of the Main Study Period (over the first 24 weeks). During the 1st course of the Main Study Period, blood samples for PK analysis were collected every week from Week 0 to Week 4, every 4 weeks from Week 4 to Week 16, followed by Week 24.
AUC0-inf: Area under the concentration-time curve from time 0 extrapolated to infinity over both doses of the 1st course",,,,,,
66358766,NCT02149121,primary,Analysis of Serum Cmax of Rituximab During the 1st Course of the Main Study Period (Over the First 24 Weeks) (ANCOVA),at Week 24 of the Main Study Period,,"For evaluation of pharmacokinetics (PK), the primary endpoint was defined as the analysis of serum AUC0-last, AUC0-inf and Cmax of rituximab during the 1st course of the Main Study Period (over the first 24 weeks). During the 1st course of the Main Study Period, blood samples for PK analysis were collected every week from Week 0 to Week 4, every 4 weeks from Week 4 to Week 16, followed by Week 24.
Cmax: Observed maximum concentration after the seocnd infusion of the 1st course",,,,,,
66358767,NCT02149121,primary,Analysis of Change From Baseline of DAS28 (CRP) at Week 24 (ANCOVA),at Week 24 of the Main Study Period,,"For evaluation of efficacy, the primary endpoint was defined as the analysis of change from baseline in disease activity measured by disease activity score 28 (DAS 28) C-reactive protein (CRP) at Week 24 between 2 treatment groups, CT-P10 and reference products (combined Rituxan and MabThera) groups. During the 1st course of the Main Study Period, DAS28 was assessed every 4 weeks from Week 0 to Week 24. DAS28 (CRP) was calculated using the following formula: DAS28 (CRP) = 0.56 X SQRT(TJC28) + 0.28 X SQRT(SJC28) + 0.36 X ln(CRP+1) + 0.014 X GH on VAS + 0.96. DAS28 (CRP) provides a number on a scale from 0 to 10 with higher values indicating greater RA disease activity.",,,,,,
65748508,NCT02158936,primary,Number of Participants Who Were Platelet Transfusion Independent During Cycles 1-4 of Azacitidine Therapy,4 cycles (Cycle = 28 days),,A subject is defined as being platelet transfusion independent if they received no platelet transfusions within the first 4 cycles of treatment with azacitidine. Subjects who died or withdrew from investigational product within the first four cycles were treated as failures (i.e. not transfusion independent) in the analysis,,,,,,
65748242,NCT02162771,primary,Area Under the Serum Concentration-time Curve at Steady State (AUCtau),Core Cycle 4 (Week 12),,"AUCtau: Area under the plasma drug concentration-time curve within a dosing interval at steady state.
PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained.",,,,,,
65748243,NCT02162771,primary,"Maximum Serum Concentration at Steady State (Cmax,ss)",Core Cycle 4 (Week 12),,"Cmax,ss: Maximum concentration of drug in plasma at steady state on administering a fixed dose at equal dosing intervals.
PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained.",,,,,,
65748244,NCT02162771,primary,Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria,During the Core Study Period (up to 8 cycles, Week 24),,"ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR) by central review.
Per 1999 IWG criteria, the disease status was assessed by using contrasted CT, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: >=75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: >=50% decrease in SPD of target lesions and no evidence of disease progression.",,,,,
65748156,NCT02163759,primary,"Percentage of Participants in Remission at Week 10 With Etrolizumab as Compared With Placebo, as Determined by the Mayo Clinic Score (MCS), GA28948 Population",Week 10,,"The Mayo Clinic Score (MCS) ranges from 0 to 12 and is a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease. Remission was defined as MCS less than or equal to (≤)2 with individual subscores ≤1 and a rectal bleeding subscore of 0. Participants were also classified as non-remitters if Week 10 assessments were missing or if they had received permitted/prohibited rescue therapy prior to assessment. Participants were stratified by concomitant treatment with corticosteroids or immunosuppressants at randomization and disease activity measured during screening (MCS ≤9/MCS ≥10); the Cochran-Mantel-Haenszel test adjusted the difference in remission rates and associated 95% confidence interval for the stratification factors.",,,,,,
65748049,NCT02165397,primary,Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 54,Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr]),,"PFS was defined as the time from date randomization to date of first IRC-confirmed disease progression (PD) assessed according to the modified VIth International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria (National Comprehensive Cancer Network [NCCN] 2014) or death due to any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death.
As the median PFS was not reached in the Ibrutinib + Rituximab arm at the time of the analysis, Kaplan Meier landmark estimate of the PFS rate at 54 months (that is, the estimated percentage of participants with PFS at Month 54) is presented.",,,,,,
64455249,NCT02167945,primary,All-Cause Death: Time to Event,"At Post-Treatment Weeks 52, 104, 156, 208, and 260",,"Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).",,,,,,
64455250,NCT02167945,primary,Liver-Related Death: Time to Event,"At Post-Treatment Weeks 52, 104, 156, 208, and 260",,"Time to liver-related death was defined as number of days from the 1st day of study drug dosing for the participant to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).",,,,,,
64455251,NCT02167945,primary,Liver Decompensation: Time to Event,"At Post-Treatment Weeks 52, 104, 156, 208, and 260",,"Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).",,,,,,
64455252,NCT02167945,primary,Liver Transplantation: Time to Event,"At Post-Treatment Weeks 52, 104, 156, 208, and 260",,"Time to liver transplantation was defined as number of days from the 1st day of study drug dosing for the participant to date of liver transplantation. All liver transplantation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).",,,,,,
64455253,NCT02167945,primary,Hepatocellular Carcinoma: Time to Event,"At Post-Treatment Weeks 52, 104, 156, 208, and 260",,"Time to hepatocellular carcinoma was defined as number of days from the 1st day of study drug dosing for the participant to date of hepatocellular carcinoma. All hepatocellular carcinoma was to be included, whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for hepatocellular carcinoma. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).",,,,,,
64455254,NCT02167945,primary,"All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event","At Post-Treatment Weeks 52, 104, 156, 208, and 260",,"Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-I; NCT02219490.",,,,,,
65747703,NCT02171429,primary,"Percentage of Participants in Remission at Week 10 With Etrolizumab Compared With Placebo, as Determined by the Mayo Clinic Score (MCS), GA28949 Population",Week 10,,"The Mayo Clinic Score (MCS) ranges from 0 to 12 and is a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease. Remission was defined as MCS less than or equal to (≤)2 with individual subscores ≤1 and a rectal bleeding subscore of 0. Participants were also classified as non-remitters if Week 10 assessments were missing or if they had received permitted/prohibited rescue therapy prior to assessment. Participants were stratified by concomitant treatment with corticosteroids or immunosuppressants at randomization and disease activity measured during screening (MCS ≤9/MCS ≥10); the Cochran-Mantel-Haenszel test adjusted the difference in remission rates and associated 95% confidence interval for the stratification factors.",,,,,,
65747271,NCT02175771,primary,Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period,Day 1 to Week 26 of the Treatment Period,,"An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.",,,,,,
65747136,NCT02177266,primary,Number of Patients With Post Cardiac Surgery Atrial Fibrillation or Post-pericardiotomy Syndrome.,Baseline to 3 months,,,,,,,,
65746687,NCT02185014,primary,Percentage of Participants With Endoscopic Improvement at Week 40 in Participants With Endoscopic Improvement at Week 0,Week 40,,"Endoscopic improvement defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of ≤4 and at least a 2-point reduction compared with Study M14-115 (NCT02185014) Baseline and no subscore greater than 1 in any individual endoscopic variable. The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The Total Score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Nonresponder imputation (NRI) was used for missing data.",,,,,,
65746600,NCT02186873,primary,Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16,Week 16,,"ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (>=)20% improvement from baseline in at least 3 of the 4 domains: patient's global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI [0=no functional impairment to 10= maximal impairment]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale [VAS]), and an absence of deterioration (defined as >=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain.",,,,,,
65746515,NCT02187159,primary,"Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo",Baseline up to Week 13 postdose,,The patient reported pain intensity daily (over the past 24 hours) on a scale of 0 = no pain to 10 = worst possible pain. The daily pain scores were averaged over 7 days to calculate the weekly ADPS.,,,,,,
65745390,NCT02203032,primary,Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40,Week 28 through Week 40,,"The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).",,,,,,
65745174,NCT02207231,primary,Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16,Week 16,,"The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).",,,,,,
65745175,NCT02207231,primary,Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16,Week 16,,"The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.",,,,,,
65745154,NCT02207244,primary,Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16,Week 16,,"The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).",,,,,,
65745155,NCT02207244,primary,Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16,Week 16,,"The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.",,,,,,
65744359,NCT02218372,primary,Percentage of Participants With Confirmed Clinical Response (CCR) at End of Treatment (EOT) +2 Days,Up to day 12,,"Initial clinical response (ICR) for ages from birth to < 2 years was defined as absence of watery diarrhea for 2 consecutive treatment days, remaining well until study drug discontinuation. ICR for ages ≥ 2 years to < 18 years was defined as improvement in number and character of bowel movements as determined by < 3 unformed bowel movements (UBMs) per day for 2 consecutive treatment days, remaining well until study drug discontinuation. CCR was defined for both age groups as not requiring further CDAD therapy within 2 days after study drug completion, and was reported with a positive (Yes) or negative (No) outcome. Resolution of diarrhea was assessed during interviews of participant/parent/legal guardian, supplemented by review of personal records (if hospitalized) and checked for presence of watery diarrhea (ages from birth to < 2 years) or number of UBMs (for ages ≥ 2 years to < 18 years).",,,,,,
65742195,NCT02247804,primary,Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2),Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2),,"IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.",,,,,,
65742196,NCT02247804,primary,IOP in the Study Eye at Week 2 (Hour 0),Week 2 (Hour 0),,"IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.",,,,,,
65742197,NCT02247804,primary,IOP in the Study Eye at Week 2 (Hour 2),Week 2 (Hour 2),,"IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.",,,,,,
65742198,NCT02247804,primary,IOP in the Study Eye at Week 6 (Hour 0),Week 6 (Hour 0),,"IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.",,,,,,
65742199,NCT02247804,primary,IOP in the Study Eye at Week 6 (Hour 2),Week 6 (Hour 2),,"IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.",,,,,,
65742200,NCT02247804,primary,IOP in the Study Eye at Week 12 (Hour 0),Week 12 (Hour 0),,"IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.",,,,,,
65742201,NCT02247804,primary,IOP in the Study Eye at Week 12 (Hour 2),Week 12 (Hour 2),,"IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.",,,,,,
65742039,NCT02250651,primary,Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2),Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2),,"IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.",,,,,,
65742040,NCT02250651,primary,IOP in the Study Eye at Week 2 (Hour 0),Week 2 (Hour 0),,"IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.",,,,,,
65742041,NCT02250651,primary,IOP in the Study Eye at Week 2 (Hour 2),Week 2 (Hour 2),,"IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.",,,,,,
65742042,NCT02250651,primary,IOP in the Study Eye at Week 6 (Hour 0),Week 6 (Hour 0),,"IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.",,,,,,
65742043,NCT02250651,primary,IOP in the Study Eye at Week 6 (Hour 2),Week 6 (Hour 2),,"IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.",,,,,,
65742044,NCT02250651,primary,IOP in the Study Eye at Week 12 (Hour 0),Week 12 (Hour 0),,"IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.",,,,,,
65742045,NCT02250651,primary,IOP in the Study Eye at Week 12 (Hour 2),Week 12 (Hour 2),,"IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.",,,,,,
65742038,NCT02251275,primary,Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs),Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment(+ 7 days),,"An adverse event (AE) was as any untoward medical occurrence associated with the use of an investigational medicinal product (IMP), whether or not considered IMP related. A TEAE was an AE that started after trial drug treatment; or if the event was continuous from baseline and was serious, related to IMP, or resulted in death, discontinuation, interruption or reduction of trial therapy. A serious TEAE included any event that resulted in: death, life-threatening, persistent or significant incapacity, substantial disruption of ability to conduct normal life functions, required inpatient hospitalization, prolonged hospitalization, congenital anomaly/birth defect, or other medically significant events as per medical judgment, that jeopardized the participant and that required medical or surgical intervention. A severe TEAE was an inability to work or perform normal daily activity. A summary of serious and all other non-serious TEAEs, regardless of causality, is located in the AE section.",,,,,,
65742022,NCT02251990,primary,Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12),12 weeks after end of all therapy (Study Week 24),,"Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification (LLOQ) of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (<LLOQ) at 12 weeks after the end of all study therapy. As pre-specified in the protocol, the Deferred Treatment Group was not included in the primary efficacy analysis.",,,,,,
65742023,NCT02251990,primary,Percentage of Participants Experiencing at Least One Adverse Event (AE) During the DB Treatment Period and First 14 Follow-up Days,DB Treatment period plus first 14 follow-up days (up to 14 weeks),,"An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. The primary safety analysis compared the safety data of the Immediate Treatment Group during the active treatment period to those of the Deferred Treatment Group during the placebo treatment period.",,,,,,
65742024,NCT02251990,primary,Percentage of Participants That Discontinued From Study Therapy Due to AEs During the DB Treatment Period,DB Treatment period (up to 12 weeks),,"An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. A participant could discontinue from treatment but continue to participate in the study as long as consent was not withdrawn. The primary safety analysis compared the safety data of the Immediate Treatment Group during the active treatment period to those of the Deferred Treatment Group during the placebo treatment period.",,,,,,
65741679,NCT02256436,primary,Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants,Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months),,"PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was assessed by blinded independent central review (BICR) in all participants up through the primary analysis database cut-off date of 07-Sep-2016.",,,,,,
65741680,NCT02256436,primary,Overall Survival (OS) - All Participants,Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months),,OS was defined as the time from randomization to death due to any cause. The OS was assessed in all participants up through the primary analysis database cut-off date of 07-Sep-2016.,,,,,,
65741681,NCT02256436,primary,PFS Per RECIST 1.1 - Participants With Programmed Cell Death-Ligand (PD-L1) Positive Tumors,Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months),,"PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by BICR in all participants who had PD-L1 positive tumors (combined positive score [CPS] ≥1%) up through the primary analysis database cut-off date of 07-Sep-2016.",,,,,,
65741682,NCT02256436,primary,OS - Participants With PD-L1 Positive Tumors,Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months),,"OS was defined as the time from randomization to death due to any cause. For the purposes of this study, participants with PD-L1 CPS ≥1% were considered to have a PD-L1 positive tumor status. OS was assessed in all participants who had PD-L1 positive tumors (CPS ≥1%) up through the primary analysis database cut-off date of 07-Sep-2016.",,,,,,
65741683,NCT02256436,primary,PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors,Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months),,"PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by BICR in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) up through the primary analysis database cut-off date of 07-Sep-2016.",,,,,,
65741684,NCT02256436,primary,OS - Participants With Strongly PD-L1 Positive Tumors,Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months),,"OS was defined as the time from randomization to death due to any cause. For the purposes of this study, participants with a PD-L1 CPS ≥10% were considered to have a strongly PD-L1 positive tumor status. The OS was assessed in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) up through the primary analysis database cut-off date of 07-Sep-2016.",,,,,,
65741169,NCT02263079,primary,Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) at 24 Weeks Post-End of Treatment/End of Untreated Observation,24 weeks post-treatment/at the end of untreated observation (Week 80),,This endpoint is defined as loss of HBsAg at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80). The percentage of responders (response rate) and 95% CI (using the Clopper-Pearson method) for the response rate are presented for each group.,,,,,,
65741132,NCT02263508,primary,Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs),The DLT evaluation period was 6 weeks from the initial administration of pembrolizumab (week 6 to 12).,,"A DLT was defined as any toxicity related to study drug which met any of the following criteria based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0:
Grade 4 non-hematologic toxicity.
Grade 3 or higher pneumonitis.
Grade 3 non-hematologic toxicity lasting > 3 days despite optimal supportive care, excluding grade 3 fatigue.
Any grade 3 or higher non-hematologic laboratory value if medical intervention was required, or the abnormality lead to hospitalization, or the abnormality persisted for > 1 week.
Febrile neutropenia grade 3 or grade 4.
Thrombocytopenia < 25 x 10^9/L if associated with a bleeding event which does not result in hemodynamic instability but required an elective platelet infusion, or a life-threatening bleeding event which resulted in urgent intervention and admission to intensive care unit.
Grade 5 toxicity (ie, death).
Any other intolerable toxicity leading to permanent discontinuation of talimogene laherparepvec or pembrolizumab.",,,,,,
65741133,NCT02263508,primary,Phase 3: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessed Using Modified RECIST 1.1,"From randomization until the data-cut-off date of 02 March 2020; median (range) time on follow-up was 25.5 (0.6, 44.7) months in the Placebo + Pembrolizumab arm and 25.6 (0.3, 45.8) months in the Talimogene Laherparepvec + Pembrolizumab arm.",,"PFS per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 is defined as the interval from randomization to the earlier event of progressive disease (PD) per modified RECIST 1.1 or death from any cause.
PD: Increase in size of target lesions from nadir by ≥ 20% and ≥ 5 mm absolute increase above nadir, or the appearance of a new lesion.
Median PFS was calculated using the Kaplan-Meier method. Participants without an event were censored at their last evaluable tumor assessment if available; otherwise on their randomization date.
The primary analysis of PFS was specified to be conducted when 407 PFS events had occurred (data cut-off date 02 March 2020).",,,,,,
65741134,NCT02263508,primary,Phase 3: Overall Survival,"From randomization until the end of study; median (range) time on follow-up was 34.8 (0.6, 58.3) months in the Placebo + Pembrolizumab arm and 36.8 (0.3, 58.4) months in the Talimogene Laherparepvec + Pembrolizumab arm.",,"Overall survival (OS) is defined as the interval from randomization to death from any cause.
Median overall survival was calculated using the Kaplan-Meier method. Participants without an event were censored at their last known alive date.",,,,,,
65741096,NCT02264990,primary,Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup,"From randomization up to the data cut-off date of 15 July 2019; median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively.",,Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. Overall survival was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.,,,,,,
65741091,NCT02265237,primary,"Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)",12 weeks after the last actual dose of study drug,,SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug.,,,,,,
65740594,NCT02272725,primary,Acute Kidney Injury,"participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours",,"The participants experiencing acute kidney injury (diagnosed by an increase in creatinine of greater or equal to 1.5x that of estimated baseline creatinine from age and weight) will be from measured point-of-care blood test of the finish line immediately following the completion of a 50 mile ultramarathon. This outcome measure is a biochemical reading, that may not necessarily be a clinical adverse event.",,,,,,
65739123,NCT02291549,primary,Nasal Obstruction/Congestion Score,Day 30,,Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to the baseline and Day 30 visits. Negative values for change from baseline indicate reduction (improvement) in nasal obstruction/congestion symptoms.,,,,,,
65739124,NCT02291549,primary,Bilateral Polyp Grade,Day 90,,"Polyp grade was determined by an independent panel of 3 sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicated reduction (improvement) in bilateral polyp grade.",,,,,,
65738920,NCT02293902,primary,Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24,Week 24,,"American College of Rheumatology (ACR) response is a composite rating scale that includes 7 variables: tender joints count (TJC [68 joints]); Swollen joints count (SJC [66 joints]); levels of an acute phase reactant (high sensitivity C-reactive protein [hs-CRP level]); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] visual analog scale [VAS]); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by health assessment questionnaire disability index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR20 response was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments.",,,,,,
65738066,NCT02305849,primary,Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12,Baseline and week 12/Early termination (ET),,"ACR20 response: greater than and equal to (≥) 20 percent (%) improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.",,,,,,
65738067,NCT02305849,primary,Change From Baseline in mTSS at Week 28,Baseline and week 28/ET,,"mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 28 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.",,,,,,
65737977,NCT02307682,primary,Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye,"Baseline, Week 48",,BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.,,,,,,
65737876,NCT02308163,primary,Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12,Baseline and Week 12/early termination (ET),,"The ACR20 response required that all criteria from (1) to (3) below be met.
Tender joint count (TJC) : ≥ 20% reduction compared with baseline.
Swollen joint count (SJC) : ≥ 20% reduction compared with baseline.
≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline
(3) ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, Subject's Global Assessment of Arthritis (SGA), Physician's Global Assessment of Arthritis (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), C-Reactive Protein (CRP).",,,,,,
65737433,NCT02313909,primary,Incidence Rate of the Composite Efficacy Outcome (Adjudicated),From randomization until the efficacy cut-off date (median 326 days),,"Components of composite efficacy outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) and systemic embolism. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.",,,,,,
65737434,NCT02313909,primary,Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated),From randomization until the efficacy cut-off date (median 326 days),,"Major bleeding event (as per ISTH), defined as bleeding event that met at least one of following: fatal bleeding; symptomatic bleeding in a critical area or organ (intraarticular, intramuscular with compartment syndrome, intraocular, intraspinal, pericardial, or retroperitoneal); symptomatic intracranial haemorrhage; clinically overt bleeding associated with a recent decrease in the hemoglobin level of greater than or equal to (>=) 2 grams per decilitre (g/dL) (20 grams per liter [g/L]; 1.24 millimoles per liter [mmol/L]) compared to the most recent hemoglobin value available before the event; clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. The results were based on classification of events that have been positively adjudicated as major bleeding events. Incidence rate estimated as number of subjects with incident events divided by cumulative at-risk time, where subject is no longer at risk once an incident event occurred.",,,,,,
65737407,NCT02314117,primary,Progression-free Survival (PFS),Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 Months),,"PFS time was measured from the date of randomization to the date of radiographic(rgr) documentation of progression(by RECIST v.1.1) or the date of death due to any cause, whichever was earlier.If a participant did not have a complete baseline tumor assessment,then the PFS time was censored at the randomization date.If a participant was not known to have died or have rgr documented progression as of the data cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. If death or progressive disease(PD) occurred after 2 or more consecutive missing rgr visits,censoring occurred at the date of the last rgr visit prior to the missed visits.If death or PD occurred after postdiscontinuation(pdis) systemic anticancer therapy,censoring occurred at the date of last rgr visit prior to the start of pdis systemic anticancer therapy. PD was defined according to RECIST v.1.1.",,,,,,
66131033,NCT02325466,primary,Mean Change in Low Shear Blood Viscosity,"baseline, week 16",,Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity from week 16 to baseline,,,,,,
66131034,NCT02325466,primary,Mean Change in High Shear Blood Viscosity,baseline and week 16,,Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity at week 16 to baseline,,,,,,
65736459,NCT02326272,primary,Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16,Week 16,,"The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.",,,,,,
65736460,NCT02326272,primary,Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16,Week 16,,"The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.",,,,,,
65736453,NCT02326298,primary,Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16,At Week 16,,"The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.",,,,,,
65736454,NCT02326298,primary,Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16,At Week 16,,"The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.",,,,,,
65735593,NCT02340221,primary,Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis,"From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)",,"PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.",,,,,,
65735594,NCT02340221,primary,PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis,"From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years)",,"PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.",,,,,,
65735264,NCT02343458,primary,Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach),at week 24,,"For the US/China approach, the primary endpoint was the change from baseline in morning pre-dose trough FEV1 at Week 24 of treatment",,,,,,
65735265,NCT02343458,primary,"Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach",over weeks 12-24,,"Change from baseline in morning pre-dose trough FEV1 over weeks 12-24, Japan approach",,,,,,
65735266,NCT02343458,primary,"Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach.",over 24 weeks,,"Change from baseline in morning pre-dose trough FEV1 over 24 weeks. Primary endpoint, EU/SK/TW approach, Secondary endpoint US/China approach.",,,,,,
65735069,NCT02346240,primary,Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12,Week 12,,"The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.",,,,,,
65735047,NCT02346721,primary,Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12),Posttreatment Week 12,,SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.,,,,,,
65735048,NCT02346721,primary,Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event,Up to 12 weeks,,,,,,,,
65733078,NCT02370498,primary,Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants,Up to 30 months (through database cut-off date of 26 Oct 2017),,"PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval [CI]) in months was reported for PD-L1 positive participants by treatment group.",,,,,,
65733079,NCT02370498,primary,Overall Survival (OS) in PD-L1 Positive Participants,Up to 30 months (through database cut-off date of 26 Oct 2017),,OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and median OS (95% CI) in months was reported for PD-L1 positive participants by treatment group.,,,,,,
65732884,NCT02373202,primary,Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs),Baseline up to Week 58,,Adverse event (AE) was defined as any untoward medical occurrence in a participant who received IMP and did not necessary have to had a causal relationship with treatment. All AEs that occurred from the first dose of the IMP administration up to 6 weeks after last dose of treatment (up to Week 58) were considered as TEAEs. SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly or a medically important event. TEAEs included both SAEs and non-SAEs.,,
65732885,NCT02373202,primary,Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities,Baseline up to Week 58,,"Criteria for potentially clinically significant vital sign abnormalities:
Systolic blood pressure (SBP) supine: <=95 mmHg and decrease from baseline (DFB) >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg
Diastolic blood pressure (DBP) supine: <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB ≥10 mmHg
SBP (Orthostatic): <=-20 mmHg
DBP (Orthostatic): <=-10 mmHg
Heart rate (HR) supine: <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm
Weight: >=5% DFB; >=5% IFB",,,,,,
65732886,NCT02373202,primary,Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities,Baseline up to Week 58,,"Criteria for potentially clinically significant ECG abnormalities:
PR Interval: >200 milliseconds (ms); >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25%
QRS Interval: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25%
QT Interval: >500 ms
QTc Bazett (QTc B): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms, IFB >60 ms
QTc Fridericia (QTc F): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms; IFB >60 ms",,,,,,
65732887,NCT02373202,primary,Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters,Baseline up to Week 58,,"Criteria for potentially clinically significant abnormalities:
Hemoglobin: <=115 g/L (Male[M]) or <=95 g/L (Female[F]); >=185 g/L (M) or >=165 g/L (F); DFB >=20 g/L
Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F); >=0.55 v/v (M) or >=0.5 v/v (F)
Red blood cells (RBC): >=6 Tera/L
Platelets: <50 Giga/L; >=50 and <100 Giga/L; >=700 Giga/L
White blood cells (WBC): <3.0 Giga/L (Non-Black [NB]) or <2.0 Giga/L (Black [B]); >=16.0 Giga/L
Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); <1.0 Giga/L
Lymphocytes: <0.5 Giga/L; >=0.5 Giga/L and <lower limit of normal (LLN); >4.0 Giga/L
Monocytes: >0.7 Giga/L
Basophils: >0.1 Giga/L
Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L)",,,,,,
65732888,NCT02373202,primary,Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters,Baseline up to Week 58,,"Criteria for potentially clinically significant abnormalities:
Glucose: <=3.9 mmol/L and <LLN; >=11.1 mmol/L (unfasted [unfas]) or >=7 mmol/L (fasted [fas])
Hemoglobin A1c (HbA1c): >8%
Total cholesterol: >=6.2 mmol/L; >=7.74 mmol/L
LDL cholesterol: >=4.1 mmol/L; >=4.9 mmol/L
Triglycerides: >=4.6 mmol/L; >=5.6 mmol/L",,,,,,
65732889,NCT02373202,primary,Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes,Baseline up to Week 58,,"Criteria for potentially clinically significant abnormalities:
Sodium: <=129 mmol/L; >=160 mmol/L
Potassium: <3 mmol/L; >=5.5 mmol/L
Chloride: <80 mmol/L; >115 mmol/L",,,,,,
65732890,NCT02373202,primary,Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters,Baseline up to Week 58,,"Criteria for potentially clinically significant abnormalities:
Creatinine: >=150 micromol/L (adults); >=30% change from baseline, >=100% change from baseline
Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to <60 mL/min; >=60 to <90 mL/min
Blood urea nitrogen: >=17 mmol/L
Uric acid: <120 micromol/L; >408 micromol/L",,,,,,
65732891,NCT02373202,primary,Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters,Baseline up to Week 58,,"Criteria for potentially clinically significant abnormalities:
Alanine Aminotransferase (ALT): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN
Aspartate aminotransferase (AST): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN
Alkaline phosphatase: >1.5 ULN
Total bilirubin (TBILI): >1.5 ULN; >2 ULN
Conjugated bilirubin(CBILI): >1.5 ULN
Unconjugated bilirubin: >1.5 ULN
ALT >3 ULN and TBILI >2 ULN
CBILI >35% TBILI and TBILI >1.5 ULN
Albumin: <=25 g/L",,,,,,
65732795,NCT02375971,primary,Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24,Week 24,,"To achieve this outcome, patients must fulfill all the following criteria, 1) survival, 2) no intervention with a second modality for ROP, 3) absence of active ROP and 4) absence of unfavorable structural outcome. Retinopathy of prematurity (ROP) is a pathologic process that occurs in the incompletely vascularized, developing retina of low birth-weight preterm neonates.",,,,,,
66130931,NCT02381652,primary,Number of Treatment-Emergent Adverse Events: Cingal 13-02 vs. Cingal 13-01,Baseline through 6 weeks post-injection,,"The primary outcome measure will compare safety results (all adverse events, whether related to the study injection or not) for Cingal 13-01 and Cingal 13-02.",,,,,,
65731360,NCT02396316,primary,Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1,From baseline to pre-dose at Week 1,,It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group.,,,,,,
65730311,NCT02410772,primary,"TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Modified Intent to Treat [MITT] Population)",Twelve months after treatment assignment,,"To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis A primary outcome status of ""favorable"", ""unfavorable"", or ""not assessable"" was assigned. For detailed definitions of outcomes please refer to: Dorman SE, at al. N Engl J Med. 2021 May 6;384(18):1705-1718.",,,,,,
65730312,NCT02410772,primary,"TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Assessable Population)",Twelve months after treatment assignment,,"To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis
To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis A primary outcome status of ""favorable"", ""unfavorable"", or ""not assessable"" was assigned. For detailed definitions of outcomes please refer to: Dorman SE, at al. N Engl J Med. 2021 May 6;384(18):1705-1718.",,,,,,
65730313,NCT02410772,primary,"Percentage Participants With Grade 3 or Higher Adverse Events During Study Drug Treatment in Control Regimen (Regimen 1 2HRZE/4HR) Compared to Experimental Regimens, Regimen 3 (2HPZM/2HPM) and Regimen 2 (2HPZ/2HP) (Safety Analysis Population)",Four months and up to 14 days after last does of after study treatment (Regimen 2 and 3) or Six months and up to 14 days after last does of after study treatment (Regimen 1),,"To evaluate the Safety of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis
To evaluate the Safety of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis Grade 3 or higher Adverse Events are collected by Clinical sites in systematic way through the laboratory tests and physical exam during regular study follow up visits and also in a non-systematic way when it was self-reported by participants during the study visits. The events are graded by site investigators per Common Terminology Criteria for Adverse Events (CTCAE V4.03",,,,,,
64226215,NCT02425644,primary,Annualized Confirmed Relapse Rate,From randomization to end of study (Week 108),,"Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple sclerosis (MS), not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicates overall functional impairment assessing Visual,Brain Stem,Pyramidal,Cerebellar,Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS in conjunction with observations and information concerning gait and use of assistance. EDSS is ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10(death due to MS).",,,,,,
65728673,NCT02434328,primary,Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye,"Baseline, Week 48",,BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.,,,,,,
65728403,NCT02437162,primary,Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 24,Week 24,,"ASAS 40 defined as improvement from baseline of greater than or equal to (>=) 40 percent (%) and absolute improvement from baseline of at least 2 on 0 to 10 centimeter (cm) scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation(0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).",,,,,,
65726374,NCT02462486,primary,Percentage of Participants With Stable Vision at Week 52,Baseline to Week 52,,"Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.",,,,,,
65726321,NCT02462928,primary,Percentage of Participants With Stable Vision at Week 52,Baseline to Week 52,,"Stable vision was defined as a loss of fewer than 15 letters in BCVA compared to baseline. BCVA was measured using an eye chart and reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.",,,,,,
65725831,NCT02472886,primary,Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12),Posttreatment Week 12,,SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.,,,,,,
65725832,NCT02472886,primary,Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE),Up to 12 weeks,,,,,,,,
65719724,NCT02540954,primary,Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye,From baseline to Week 52,,"Visual function was assessed with the procedure from the ETDRS adapted for the Age Related Eye Disease Study using charts with 70 letters at a starting distance of 4 meters. Charts are organized in 14 lines of decreasing size with 5 letters each. Participants reading up to 19 letters at 4 meters were tested at 1 meter to read the first 6 lines. The score equals the sum of letters read at 1 meter and 4 meters. If more than 19 letters are read at 4 meters the score equals the number of letters read plus 30. The score range is 0 to 100, and a higher score represents better visual function.",,,,,,
1 id nct_id outcome_type measure time_frame population description Scalar Unit
2 65857719 NCT00967798 primary Number of Participants With Conversion to Cystic Fibrosis Related Diabetes Month 15 The number of participants with conversion to cystic fibrosis related diabetes was determined. 15 months
3 65857602 NCT00968968 primary Progression-free Survival Time from randomization until disease progression or death, approximately 4 years Progression-free survival (PFS) with lapatinib plus trastuzumab versus trastuzumab alone. Progression-free survival (PFS) is defined as the time from randomization to the earliest date of disease progression (with radiological evidence) or death from any cause, or to last contact date up to 21Feb2014. Disease Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1), a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum diameters recorded since the treatment started (the sum must have an absolute increase from nadir of 5mm), or an unequivocal progression of existing non-target lesions, or the appearance of new lesions. ?? ??
4 66348662 NCT01067521 primary Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression Day 1 to 12 months Relapses were monitored throughout the study. During the PC Period, two neurologists/physicians assessed subjects' general medical and neurological evaluations separately. A relapse was defined as the appearance of 1+ new neurological abnormalities or the reappearance of 1+ previously observed neurological abnormalities lasting >= 48 hours and immediately preceded by an improving neurological state of at >=30 days from onset of previous relapse. An event was counted as a relapse only when the subject's symptoms were accompanied by observed objective neurological changes, consistent with >= one of the following: - An increase of >= 0.5 in the Expanded Disability Status Scale (EDSS) score as compared to previous evaluation. - An increase of one grade in the actual score of >=2 of the 7 functional systems (FS), as compared to previous evaluation. - An increase of 2 grades in the actual score of one FS as compared to the previous evaluation. Adjusted mean values are displayed. 12 months
5 66348663 NCT01067521 primary Annualized Rate of Confirmed Relapses Comparing Early Starters to Delayed Starters Estimated by Negative Binomial Regression Day 1 up to 6.5 years The annualized relapse rate (ARR) was calculated for the study by dividing the cumulative number of confirmed relapses by the number of person-years of exposure to treatment. The analysis of the annualized relapse rate is based on estimating a contrast (early start vs delayed start) derived from a baseline-adjusted, Negative Binomial Regression model to the number of confirmed relapses observed during study (post randomization) with an "offset" based on the log of exposure to treatment. ?? ??
6 65846774 NCT01069705 primary Number of Participants With Adverse Events (AEs) From time of first administration of study drug until study completion (up to 169 days) An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. ?? ??
7 65846775 NCT01069705 primary Number of Participants With Serious Adverse Events (SAEs) From time of consent to 4 weeks after study completion (up to 199 days) A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. ?? ??
8 65846776 NCT01069705 primary Percentage of Participants With a Decrease of ≥20% in Forced Expiratory Value in One Second (FEV1) Percent (%) Predicted From Pre-dose to 30-minute Post-dose Pre-dose and post-dose of Day 1 and Day 29 of every Cycle (5, 6, 7) Airway Reactivity >= 20% relative decrease in FEV1% predicted from pre-dose to 30 minutes post-dose. Relative Change = 100 * (30 minutes Post-dose - Pre-dose)/Pre-dose assessed by the number and percentage of participants with a decrease of ≥ 20% in FEV1 % predicted from pre-dose to 30 minutes post-dose. 29 days
9 65846777 NCT01069705 primary Percentage of Participants With Frequency Decrease From Baseline in the Post-baseline Audiology Tests Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57) Auditory acuity of participants was measured using a standard dual-channel audiometer at frequencies from 250 to 8000 Hertz, and an audiogram (pure-tone air conduction) and tympanogram were performed by an audiologist. The categories reported includes >= 10dB decrease in 3 consecutive frequencies in either ear, >= 15dB decrease in 2 consecutive frequencies in either ear, and >= 20dB decrease in at least one frequency in either ear
10 65846254 NCT01074047 primary Kaplan-Meier Estimates for Overall Survival Day 1 (randomization) to 40 months Overall Survival was defined as the time from randomization to death from any cause. Overall survival was calculated by the formula: date of death - date of randomization + 1. Participants surviving at the end of the follow-up period or who withdrew consent to follow-up were censored at the date of last contact. Participants who were lost to follow-up were censored at the date last known alive.
11 65845812 NCT01077518 primary Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC) From randomization to the date of first documented disease progression or death due to any cause (67.5 months) PFS is defined as the time interval between randomization until disease progression or death (due to any cause).
12 65845533 NCT01079806 primary Percentage of Participants Who Achieved a Combination of Hepatitis B Virus (HBV) DNA Suppression and Hepatitis B e Antigen (HBeAg) Seroconversion at Week 48 At Week 48 Suppression=HBV DNA<50 IU/mL (approximately 300 copies/mL) using the Roche COBAS TaqMan HBV Test for use with the High Pure System assay; seroconversion=undetectable HBeAg and detectable anti-hepatitis B e antibodies. While the analysis of the primary endpoint was based on a randomized sample size of 123 participants (the Primary Cohort), the size of the overall study population was augmented to 180 randomized participants to meet global regulatory requirements.
13 65843612 NCT01099579 primary Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation From Day 1 to Week 48 AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
14 65843613 NCT01099579 primary Number of Participants With Laboratory Test Results With Worst Toxicity of Grade 3-4 After Day 1 to Week 48 ALT=alanine aminotransferase; SGPT=serum glutamic-pyruvic transaminase; AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; ULN=upper limit of normal. Grading by the National Institute of Health Division of AIDs and World Health Organization criteria. Hemoglobin (g/dL): Grade (Gr)1=9.5-11.0; Gr 2=8.0-9.4; Gr 3=6.5-7.9; Gr 4=<6.5. Neutrophils, absolute (/mm^3): Gr 1=>=1000-<1500; Gr 2= >=750-<1000; Gr 3=>=500-<750; Gr 4=<500. ALT/SGPT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=>10. AST/SGOT (*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5; Gr 3=5.1-10; Gr 4=>10. Alkaline phosphatase(*ULN): Gr 1=1.25-2.5; Gr 2=2.6-5: Gr 3=5.1-10; Gr 4=>10. Total bilirubin (*ULN): Gr 1=1.1-1; Gr 2=1.6-2.5; Gr 3=2.6-5; Gr 4=>5. Amylase (*ULN): Gr 1=1.10-39; Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Lipase (*ULN): Gr 1=1.10-1.39: Gr 2=1.40-2; Gr 3=2.10-5.0; Gr 4=>5.0. Uric acid (mg/dL): Gr 1=7.5-10.0; Gr 2=10.1-12.0; Gr 3=12.1-15.0; Gr 4=>15.
15 65843614 NCT01099579 primary Electrocardiogram Changes From Baseline in PR Interval, QTC Bazett, and QTC Fridericia at Week 48 From Baseline to Week 48 Electrocardiogram parameters were measured at baseline for QTC Bazett, QTC Fridericia, and PR interval. The mean change from baseline at week 48 is reported by arm in milliseconds.
16 65843615 NCT01099579 primary Number of Participants With Centers for Disease Control (CDC) Class C AIDS Events From Day 1 to Week 48 CDC Class C events are AIDS-defining events that include recurrent bacterial pneumonia (>=2 episodes in 12 months); candidiasis of the bronchi, trachea, lungs, or esophagus; invasive cervical carcinoma; disseminated or extrapulmonary coccidioidomycosis; extrapulmonary cryptococcosis; chronic intestinal cryptosporidiosis (>1 month); cytomegalovirus disease; HIV-related encephalopathy; herpes simplex: chronic ulcers, or bronchitis, pneumonitis, or esophagitis; disseminated or extrapulmonary histoplasmosis; chronic intestinal isosporiasis; Kaposi sarcoma; immunoblastic or primary brain Burkitt lymphoma; mycobacterium avium complex, kansasii, or tuberculosis; mycobacterium, other species; Pneumocystis carinii pneumonia; progressive multifocal leukoencephalopathy; Salmonella septicemia; recurrent toxoplasmosis of brain; HIV wasting syndrome (involuntary weight loss >10% of baseline body weight) with chronic diarrhea or chronic weakness and documented fever for ≥1 month.
17 65843546 NCT01100502 primary Progression-free Survival by Independent Review Up to approximately 4 years Time from date of randomization to the first documentation of disease progression by independent review or to death due to any cause, whichever comes first
18 65842497 NCT01111539 primary Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14) Week 8 to Week 14 The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change from Week 8 indicates improvement.
19 65842494 NCT01111552 primary Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14) Week 8 to Week 14 The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change from Week 8 indicates improvement. Last observation carried forward (LOCF) method was used for analyses.
20 66377721 NCT01111565 primary Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14) Week 8 to Week 14 The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. Last observation carried forward (LOCF) method was used for analyses.
21 65841648 NCT01120184 primary Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as [number of participants with event divided by the number analyzed] multiplied by 100.
22 65841649 NCT01120184 primary Progression-Free Survival (PFS) According to IRF Assessment Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose) Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding confidence intervals (CIs) were computed using the Brookmeyer-Crowley method.
23 65841587 NCT01120600 primary Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 24 Baseline and Month 24 Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.
24 65841588 NCT01120600 primary Number of Participants Who Experienced an Adverse Event (AE) Up to 24 months (plus 14 days) after first dose of study drug An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
25 65841589 NCT01120600 primary Number of Participants Who Discontinued Treatment Due to an AE Up to 24 months after first dose of study drug An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
26 66384256 NCT01123707 primary Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs), Severe (Grade 3 or Higher) TEAEs, and Discontinuations From the Trial Due to TEAEs From first dose up to 30 days post last dose (Up to approximately 40 weeks) An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention. TEAE is defined as an adverse event that started after start of study drug treatment. The Common Terminology Criteria for Adverse Events v3.0 (CTCAE) was used to determine the severity wherein Grade 1=mild AE, Grade 2=moderate AE, Grade 3=severe AE, Grade 4=life-threatening or disabling AE, Grade 5=death related to AE.
27 65840407 NCT01129882 primary Number Of Participants Reporting Severe Treatment-Emergent Adverse Events (TEAE) Baseline to Month 97 (+/- 3 days) A TEAE was defined as an AE that started after start of investigational medicinal product (IMP) treatment or if the event was continuous from baseline and was serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of IMP. A severe AE was one that caused inability to work or perform normal daily activity. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
28 65838665 NCT01148225 primary Number of Participants With Adverse Events Baseline to Final Visit (up to 366 weeks) An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset date on or after the first dose of study drug and up to 70 days after the last dose. See the Adverse Event section for details.
29 65838666 NCT01148225 primary Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values Baseline to Final Visit (Up to 366 weeks) PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 ≥ Grade 3. Abbreviations used include g=grams L=liters.
30 65838667 NCT01148225 primary Chemistry: Number of Participants With PCS Values Baseline to Final Visit (Up to 366 weeks) PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 ≥ Grade 3. Abbreviations include ALT/SGPT=alanine aminotransferase/serum glutamate pyruvate transaminase AST/SGOT=aspartate aminotransferase/serum glutamate oxaloacetate transaminase g/L=grams/liter mmol/L=millimoles/liter ULN=upper limit of normal.
31 65838668 NCT01148225 primary Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit Baseline to Final Visit (Up to 366 weeks) Heart rate (beats per minute) was measured while the participant was sitting.
32 65838669 NCT01148225 primary Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit Baseline to Final Visit (Up to 366 weeks) Respiratory rate (respirations per minute) was measured while the participant was sitting.
33 65838670 NCT01148225 primary Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit Baseline to Final Visit (Up to 366 weeks) Temperature was measured while the participant was sitting.
34 65838671 NCT01148225 primary Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit Baseline to Final Visit (Up to 366 weeks) Blood pressure was measured while the participant was sitting. Abbreviations used include mmHg=millimeters of mercury.
35 65832687 NCT01201356 primary Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
36 65968081 NCT01213017 primary the change from baseline in synovitis and bone edema RAMRIS score. 6 weeks
37 65831375 NCT01214421 primary Percent Change From the Baseline in Total Kidney Volume (TKV) for Study 156-04-251 Participants Enrolled in This Study (156-08-271) Study Baseline (Prior to Day 1 in Study 156-04-251) to Month 24 in this study (Study 156-08-271) Total kidney volume is a measure of disease progression in the ADPKD participants. Kidney volume was assessed in T1-weighted magnetic resonance images collected at each study site and sent to a central reviewing facility. At the central reviewing facility, radiologists used proprietary software to measure the volume of both kidneys in participants continuing from previous study (156-04-251) at Month 24 of this study (156-08-271) comparing change in TKV for the early-treated (those previously treated with tolvaptan) to delayed-treated (those previously treated with placebo). The percent change in the volume of both kidneys combined was analysed using mixed-effect model repeated measures (MMRM) analysis and reported. This outcome measure was analyzed only in the participants enrolled from the previous study - 156-04-251, as pre-specified in the protocol.
38 65829319 NCT01234337 primary Progression-free Survival (PFS) Assessed by the Independent Review Panel According to Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 From randomization of the first participant until approximately 3 years or until disease radiological progression PFS was defined as the time from date of randomization to disease progression, radiological or death due to any cause, whichever occurs first. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.
39 66377362 NCT01239797 primary Median Progression Free Survival (PFS) From randomization up to 326 events (up to approximately 38 months) Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.
40 66377363 NCT01239797 primary Objective Response Rate (ORR) From randomization up to approximately 38 months Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.
41 64468586 NCT01285557 primary Overall Survival (OS) From the date of randomization until disease progression or death, cut-off date: 15 August 2014 (approximately 40 months) OS was defined as the time from randomization to the date of death for the ITT population. Participants who did not die were censored at the date last known to be alive. Analysis was performed by using Kaplan-Meier method.
42 65818940 NCT01335698 primary Number of Participants Who Died and With Adverse Events (AEs) Leading to Discontinuation, Hyperbilirubinemia, Jaundice, First-degree Arterioventricular Block, Tachycardia, and Rash on ATV Powder Day one to week 300 (approximately 22-Jan-2018) AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.
43 65818941 NCT01335698 primary Number of Participants Who Experienced a SAE on ATV Powder Day one to week 300 (approximately 22-Jan-2018) SAE= any of the the following: is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event (defined as a medical event(s) that may not be immediately life threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the subject or may require intervention [eg, medical, surgical] to prevent one of the other serious outcomes listed in the definition above.) Examples of such events include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization
44 65818942 NCT01335698 primary Number of Participants With A Center of Disease Control and Prevention (CDC) Class C AIDS Event on ATV Powder Day one to week 300 (approximately 22-Jan-2018) The CDC disease staging system assesses the severity of HIV disease by CD4 cell counts and by the presence of specific HIV-related conditions. CD4 counts are classified as 1: ≥500 cells/µL, 2: 200-499 cells/µL, and 3: <200 cells/µL. Children with HIV infection are also classified in each of several categories. Category N: Not symptomatic. Category A: Mildly symptomatic. Category B: Moderately symptomatic. Category C: Severely symptomatic.
45 65818943 NCT01335698 primary Number of Participants With Laboratory Test Results Meeting the Criteria for Grade 3-4 Abnormality on ATV Powder Day one to week 300 (approximately 22-Jan-2018) Criteria of the Division of AIDS for grading the severity of adult and pediatric adverse events as follows: Grade (Gr) 1=mild; Gr 2=moderate; Gr 3=severe; Gr 4=potentially life-threatening. Neutrophils (absolute) (adult and infants >7 days): Gr 1=1.000-1300/mm^3; Gr 2=750-999 mm^3; Gr 3=500-749 mm^3; Gr 4= <500 mm^3. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase: Gr 1=1.25-2.5*upper limit of normal (ULN); Gr 2=2.6-5.0*ULN; Gr 3=5.1-10.0*ULN; Gr 4= >10.0*ULN. Bilirubin, total (adults and infants >14 days): Gr 1=1.1-1.5*ULN; Gr 2=1.6-2.5*ULN; Gr 3=2.6-5.0*ULN; Gr 4= >5.0*ULN. Lipase: Gr 1=1.1-1.5*ULN; Gr 2=1.6-3.0*ULN; Gr 3=3.1-5.0*ULN; Gr 4= >5.0*ULN. Bicarbonate, serum low: Gr 1=16.0 mEq/L-<lower limit of normal; Gr 2=11.0-15.9 mEq/L; Gr 3=8.0-10.9 mEq/L; Gr 4= <8 mEq/L. By criteria of the World Health Organization: Amylase: Gr 1=1.0-1.39*ULN; Gr 2=1.40-2.09*ULN; Gr 3.=2.10-5.0*ULN; Gr 4= >5.0*ULN.
46 65815965 NCT01368497 primary Proportion of Participants With Hepatitis B e Antigen (HBeAg) Loss & Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels ≤1,000 International Units (IU) Per Milliliter (mL) End of follow-up (up to 96 weeks)
47 65815966 NCT01368497 primary Incidence of Adverse Events (AEs) Per Person-Year From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks) The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.
48 65815967 NCT01368497 primary Incidence of Serious Adverse Events (SAEs) Per Person-Year From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks) The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.
49 65815899 NCT01369199 primary Proportion of Participants With HBeAg Loss (Lack of Detectable HBeAg) AND HBV DNA ≤1,000 IU/mL End of follow-up (up to 96 weeks) Lack of data was considered to be treatment failure.
50 65815900 NCT01369199 primary Incidence of Adverse Events (AEs) Per Person-Year of Observation From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks) The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.
51 65815901 NCT01369199 primary Incidence of Serious Adverse Events (SAEs) Per Person-Year From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks) The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.
52 64189362 NCT01400776 primary Change From Baseline in Participant's Self-Assessment of Severity of Vaginal Dryness to Week 12/Final Visit Baseline (Day 0) to Week 12/Final Visit The severity of vaginal dryness was assessed and recorded on a questionnaire by the participants using the following 4 point scale where, 0=None (The symptom is not present), 1=Mild (The symptom is present but may be intermittent; does not interfere with participants activities or lifestyle), 2=Moderate (The symptom is present. Participant is usually aware of the symptom, but activities and lifestyle are only occasionally affected), and 3=Severe (The symptom is present. Participant is usually aware and bothered by the symptom and have modified participant's activities and/or lifestyle due to the symptom. The negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
53 64189363 NCT01400776 primary Change From Baseline in Vaginal pH to Week 12/Final Visit Baseline (Day 0) to Week 12/Final Visit Vaginal pH was obtained at final visit of the study. The pH was a numeric value from a scale of 0 to 14 expressing the acidity or alkalinity of the vaginal fluids where 7 was neutral, lower values were more acidic (values of 0-6) and higher values more alkaline (values of 8-14). A negative change from Baseline indicates improvement. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
54 64189364 NCT01400776 primary Change From Baseline in Percentage of Vaginal Superficial Cells to Week 12/Final Visit Baseline (Day 0) to Week 12/Final Visit Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of superficial cells. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
55 64189365 NCT01400776 primary Change From Baseline in Percentage of Vaginal Parabasal Cells to Week 12/Final Visit Baseline (Day 0) to Week 12/Final Visit Vaginal wall smears were collected from each participant. The smears were sent to the central laboratory for analysis to determine the percentage of parabasal cells. Week 12/Final Visit is defined as the last available postbaseline assessment up to Week 12.
56 65812203 NCT01413178 primary Progression-Free Survival (PFS) 3 years after transplant Participants that are still alive and without Multiple Myeloma 3 years after Stem cell Transplantation.
57 65811960 NCT01416441 primary Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs and TEAEs Leading Treatment Discontinuation From signing of the informed consent up to 30 days after the last dose (Up to Week 52) An Adverse Event (AE) is defined as any untoward medical occurrence in a participant enrolled in a clinical trial and which did not necessarily have a causal relationship with the study medication. Treatment emergent adverse events (TEAE) are adverse events occurring after the onset of study drug administration.
58 65811961 NCT01416441 primary Number of Participants With Clinically Significant Changes in Laboratory Parameter Values Baseline to Week 52 The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Participants with potentially clinically significant lab values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria were reported. Any value outside the normal range was flagged for the attention of the investigator who assessed whether or not a flagged value is of clinical significance.
59 65811962 NCT01416441 primary Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values Baseline to Week 52 Incidence of clinically relevant abnormal ECG values were reported as change from Baseline in heart rate (Tachycardia - ≥15 beats per minute (bpm), Bradycardia ≤15 bpm; Rhythm (Sinus tachycardia ≥15 bpm increase, Sinus bradycardia decrease of ≥15 bpm from Baseline); Presence of - supraventricular premature beat; ventricular premature beat; supraventricular tachycardia; ventricular tachycardia; atrial fibrillation and flutter. Conduction - Presence of primary, secondary or tertiary atrioventricular block, left bundle-branch block, right bundle-branch block, pre-excitation syndrome, other intraventricular conduction blocked QRS ≥0.12 second increase of ≥0.02 second. Acute, subacute or old Infarction, Presence of myocardial ischemia, symmetrical T-wave inversion. Increase in QTc - QTc ≥450 msec ≥10% increase. Any clinically significant change from Baseline assessed by the Investigator are reported.
60 65811963 NCT01416441 primary Number of Participants With Emergence of Suicidal Ideation, TEAEs Related to Suicide and Suicidality and Suicide Ideation From the Potential Suicide Events Recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline to Week 52 Suicidality was defined as reporting at least one occurrence of any suicidal behavior or suicidal ideation. Suicidal behavior was defined as reporting any type of suicidal behaviors (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Suicidal ideation was defined as reporting any type of suicidal ideation. The suicidal ideation intensity total score is the sum of intensity scores of 5 items (frequency, duration, controllability, deterrents, and reasons for ideation). The score of each intensity item ranges from 0 (none) to 5 (worst) which leads to the range of the total score from 0 to 25. A missing score of any item resulted in a missing total score. If no suicidal ideation was reported, a score of 0 was given to the intensity scale.
61 65811964 NCT01416441 primary Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Score Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52) The AIMS Scale is an extrapyramidal symptoms (EPS) rating scale. The AIMS is a 12 item scale. The first 10 items e.g. facial and oral movements (items 1-4), extremity movements (items 5 and 6), trunk movements (item 7), investigators global assessment of dyskinesia (items 8 to 10) are rated from 0 to 4 (0=best, 4=worst). Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28. A negative change from Baseline indicates improvement.
62 65811965 NCT01416441 primary Mean Change From Baseline in Body Mass Index (BMI) Baseline and Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52) The BMI kilogram/meter square (i.e. kg/m^2) was calculated from the Baseline height and the weight at the current visit using one of the following formulae, as appropriate: Weight (kg) divided by [Height (meters)]^2.
63 65811966 NCT01416441 primary Number of Participants With Clinically Significant Changes in Vital Signs Baseline to Week 52 Vital signs assessments included orthostatic (supine and standing) blood pressure (BP) measured as millimeter of mercury [mmHg]), heart rate, (measured in beats per minute [bpm]), body weight (measured in kilograms [kg]) and body temperature. Incidence of clinically relevant abnormal values in heart rate, systolic and diastolic blood pressure and weight were identified based on pre-defined criteria. Orthostatic assessments of blood pressure and heart rate were made after the participant has been supine for at least 5 minutes and again after the participant has been standing for approximately 2 minutes, but not more than 3 minutes.
64 65811967 NCT01416441 primary Mean Change From Baseline in Simpson Angus Scale (SAS) Score Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 52; Last Visit (Week 52 or early termination Visit before Week 52) The SAS is a rating scale used to measure Extrapyramidal symptoms (EPS). The SAS scale consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia), with each item rated from 0 to 4, with 0 being normal and 4 being the worst. The SAS Total score is sum of ratings for all 10 items, with possible Total scores from 0 to 40. A negative change from Baseline indicates improvement.
65 65811968 NCT01416441 primary Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Score Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) The BARS was an EPS rating scale. The BARS was used to assess the presence and severity of akathisia. This scale consists of 4 items. Only the 4th item, the Global Clinical Assessment of Akathisia, was evaluated in this trial. This item is rated on a 6 point scale, with 0 being best (absent) and 5 being worst (severe akathisia). A negative change from Baseline indicates improvement.
66 65811969 NCT01416441 primary Mean Change From Baseline in Average Score of Attention-Deficit Disorder/Attention-Deficit Hyperactivity Disorder (ADD/ADHD) Sub-scale of the Swanson, Nolan and Pelham-IV (SNAP-IV) Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) The SNAP-IV, ADHD Inattention subscale contains 19 items, items 1 to 9 measure inattention, items 11 to 19 measure hyperactivity/impulsivity, and item 10 for inattention domain that scores the intensity of each item during the last seven days on a 0 to 3 scale (0=not at all, 1=just a little, 2=pretty much, 3=very much). The lowest possible score is 0; highest is 57. The negative change from Baseline indicates improvement.
67 65811970 NCT01416441 primary Mean Change From Baseline in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) Total Score Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) The CY-BOCS is used to assess characteristics of obsession and compulsion for the week prior to the interview. Nineteen items are rated in the CY-BOCS, but the total score is the sum of only items 1 to 10 (excluding items 1b and 6b). The obsession and compulsion subtotals are the sums of items 1 to 5 (excluding 1b) and 6 to 10 (excluding 6b), respectively. A missing value for any CY-BOCS item scale could result in a missing total score or obsession and compulsion subtotals of which the item scale is a component. At baseline, the full CY-BOCS interview is conducted. At all post-baseline time points, the "Questions on Obsessions" (items 1 to 5) and "Questions on Compulsions" (items 6 to 10) are reviewed and the target symptoms identified at baseline are the primary focus for rating severity. CY-BOCS total score could range from 0 to 40. Higher scores indicate worse outcome. A negative change from Baseline indicates improvement.
68 65811971 NCT01416441 primary Mean Change From Baseline in Children's Depression Rating Scale Revised (CDRS-R) Total Score Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) The CDRS-R is composed of 17 interviewer-rated symptom areas: impaired schoolwork, difficulty having fun, social withdrawal, appetite disturbance, sleep disturbance, excessive fatigue, physical complaints, irritability, excessive guilt, low self-esteem, depressed feelings, morbid ideas, suicidal ideas, excessive weeping, depressed facial affect, listless speech, and hypoactivity. The CDRS-R total score is the sum of scores for the 17 symptom areas. A missing value for any CDRS-R item scale or a not rated item scale (indicated by the value of 0) could result in a missing total score. The CDRS-R total score is the sum of scores for the 17 symptom areas and could range from 17 to 113 with higher values indicating worse outcome. A negative change from Baseline indicates improvement.
69 65811972 NCT01416441 primary Mean Change From Baseline in Pediatric Anxiety Rating Scale (PARS) Total Severity Score Baseline and Weeks 4, 8, 12, 16, 20, 24, 32,40, 52; Last Visit (Week 52 or early termination Visit before Week 52) The PARS has 2 sections: the symptom checklist and the severity items. The symptom checklist is used to determine the child's repertoire of symptoms during the past week. Information is elicited from the child and parent(s) and the rater then combines information from all informants using his/her best judgment. The 7-item severity list is used to determine severity of symptoms and the PARS total score. The time frame for the PARS rating is the past week. Only those symptoms endorsed for the past week are included in the symptom checklist and rated on the severity items. The PARS total severity score is the sum of items 2, 3, 5, 6, and 7. The total severity score ranges from 0 to 25, with 25 being the worst. Codes "8" (Not applicable) and "9" (Does not know) are not included in the summation (ie, equivalent to a score of 0 in the summation). A negative change from Baseline indicates improvement.
70 65811973 NCT01416441 primary Mean Change From Baseline in Body Weight Baseline to Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52)
71 65811974 NCT01416441 primary Mean Change From Baseline in Waist Circumference Baseline to Weeks 12, 24, 52 and Last Visit (Week 52 or early termination Visit before Week 52) Waist circumference was recorded before a participant's meal and at approximately the same time at each visit. Measurement was accomplished by locating the upper hip bone and the top of the right iliac crest and placing the measuring tape in a horizontal plane around the abdomen at the level of the crest. Before reading the tape measure, the assessor assured that the tape was snug, but did not compress the skin, and is parallel to the floor. The measurement was made at the end of a normal exhalation.
72 65811875 NCT01418339 primary Change From Baseline in Yale Global Tic Severity Scale (YGTSS) - Total Tic Score (TTS) Baseline to Week 8 The YGTSS is a semi-structured clinical interview designed to measure the tic severity. This scale consisted of a tic inventory, with 5 separate rating scales to rate the severity of symptoms, and an impairment ranking. Ratings were made along 5 different dimensions on a scale of 0 to 5 for motor and vocal tics, each including number, frequency, intensity, complexity, and interference. The YGTSS TTS was the summation of the severity scores of motor and vocal tics. The TTS ranged from 0 (none) to 50 (severe) with a higher score represent more severe symptoms (greater reduction from baseline for greater improvement). Mixed Effect Repeated Measure Model (MMRM) analysis was performed.
73 65808618 NCT01449929 primary Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48 Week 48 Assessment was done using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm.This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks). Modified Intent-To-Treat Exposed (mITT-E) Population:all randomized participants who received at least one dose of investigational product
74 64189352 NCT01455597 primary Number of Participants With Endometrial Biopsy Results at Final Visit Final Visit (Day closest to Day 281) The endometrial biopsy results was categorized as: normal results categorized as atrophic/inactive or proliferative, unsatisfactory with endometrial thickness ≤4 mm and missing biopsy with endometrial thickness ≤4 mm; abnormal results categorized as polyp, hyperplasia, and carcinoma; unknown result categorized as unsatisfactory with endometrial thickness >4 mm, missing biopsy with endometrial thickness >4 mm, unsatisfactory without transvaginal ultrasonography (TVU) result and missing biopsy without TVU result. The duration of estradiol exposure was combination of studies PR-04409.3 and PR-04509.
75 64308049 NCT01459679 primary Mean change in maximum corneal curvature (Kmax) from baseline Month 6 or 12
76 65807389 NCT01461928 primary Maintenance II: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia From randomization (Maintenance II) up to disease progression or death, whichever occurs first (up to approximately 24 months) Progression free survival from randomization (PFSrand) is defined as the time from date of randomization to the date of first documented disease progression or death, whichever occurs first. One participant died in Induction before randomization and one participant died in Maintenance II Observation arm due to an SAE and were not considered in the analysis as no death page was completed. The Observation arm did not include one participant with AE outcome of death reported retrospectively 2 months after discontinuation from study (censored as having no event on Day 456 post-randomization).
77 65807162 NCT01463306 primary Number of Participants With Treatment Emergent Adverse Events (AEs), Treatment Emergent Serious Adverse Events (SAEs), Treatment Related AEs and Treatment Related SAEs Baseline (Day 1) up to 13 Months An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death initial or prolonged inpatient hospitalization life-threatening experience (immediate risk of dying) persistent or significant disability/incapacity congenital anomaly. Treatment emergent are events between first dose of study drug and up to 28 days after last dose of study drug (up to 13 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator.
78 65807163 NCT01463306 primary Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings up to 12 Months Baseline up to 12 Months Physical examination assessed: general appearance, dermatological, head and eyes, ears, nose, mouth, and throat, pulmonary, cardiovascular, abdominal, genitourinary (optional), lymphatic, musculoskeletal/extremities. Neurological examination assessed: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation, coordination and gait. Investigator judged clinically significant change from baseline in physical and neurological examination findings.
79 65807164 NCT01463306 primary Number of Participants Meeting Pre-defined Criteria for Vital Signs Abnormalities Baseline up to 12 months Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) >=30 millimeter of mercury (mmHg) maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) >=20 mmHg.
80 65807165 NCT01463306 primary Number of Participants With Tanner Staging Evaluation at Baseline Baseline (Day 1) Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
81 65807166 NCT01463306 primary Number of Participants With Tanner Staging Evaluation at Month 12 Month 12 Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics).
82 65807167 NCT01463306 primary Number of Participants With >=7 Percent (%) Change From Baseline in Body Weight up to 12 Months Baseline up to 12 Months In this outcome measure number of participants with increase and decrease of >=7% in body weight, from baseline up to 12 months are reported.
83 65807168 NCT01463306 primary Absolute Values for Body Height at Baseline Baseline
84 65807169 NCT01463306 primary Absolute Values for Body Height at Month 12 Month 12
85 65807170 NCT01463306 primary Number of Participants With Incidence of Laboratory Abnormalities Baseline up to 12 Months Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell(RBC) count: <0.8*lower limit of normal(LLN), platelet: <0.5*LLN/greater than (>)1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN/>1.5*ULN, lymphocyte, neutrophil- absolute/%:<0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte- absolute/%:>1.2*ULN; total/direct/indirect bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN/>1.2*ULN; thyroxine, thyroid stimulating hormone <0.8*LLN/>1.2*ULN; cholesterol, triglycerides:> >1.3*ULN; blood urea nitrogen, creatinine:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium: <0.9*LLN or >1.1*ULN; glucose <0.6*LLN/>1.5*ULN, creatine kinase>2.0*ULN; urine (specific gravity <1.003/>1.030, pH <4.5/>8, glucose, ketones, protein: >=1, WBC, RBC:>=20, bacteria >20, hyaline casts/casts >1); prothrombin (PT), PT international ratio>1.1*ULN.
86 65807171 NCT01463306 primary Number of Participants With Maximum Change From Baseline up to 12 Months in 12-Lead Electrocardiogram (ECG) Parameters Baseline up to 12 Months Categories for which data is reported are: 1) maximum (max) PR interval increase from baseline (IFB) (millisecond [msec]) percent change (PctChg) >=25/50%; 2) maximum QRS complex increase from baseline (msec) PctChg>=50%; 3) maximum QTcB interval (Bazett's correction) increase from baseline (msec): change >=30 to <60; change >=60; 4) maximum QTcF interval (Fridericia's correction) increase from baseline (msec): change >=30 to <60; change >=60. 'PctChg>=25/50%': >= 25% increase from baseline when baseline ECG parameter is > 200 msec, and is >= 50% increase from baseline when baseline ECG parameter is non-missing and <=200 msec.
87 65807172 NCT01463306 primary 28-Days Seizure Rate at Week 1 Week 1 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
88 65807173 NCT01463306 primary 28-Days Seizure Rate at Month 1 Month 1 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
89 65807174 NCT01463306 primary 28-Days Seizure Rate at Month 2 Month 2 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
90 65807175 NCT01463306 primary 28-Days Seizure Rate at Month 4 Month 4 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
91 65807176 NCT01463306 primary 28-Days Seizure Rate at Month 6 Month 6 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
92 65807177 NCT01463306 primary 28-Days Seizure Rate at Month 9 Month 9 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
93 65807178 NCT01463306 primary 28-Days Seizure Rate at Month 12/Early Termination Month 12/Early Termination 28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes.
94 64308011 NCT01470131 primary Progression Free Survival Analysis to be conducted after a minimum of 201 events
95 66358803 NCT01471444 primary Progression-Free Survival (PFS) From day of transplant to disease of progression or death of any cause, whichever came first, assessed up to 5 years Number of events with progression free survival. (Progression is defined as more than 5% blast in the peripheral blood or bone marrow biopsy.) or expired from treatment related mortality post transplant.
96 66358799 NCT01510184 primary Overall Survival (OS) for Living Participants From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years) OS was the time from randomization to death. In living participants, survival time was censored on the last date that participants were known to be alive. OS for living participant was calculated as (end of study date/last visit date - randomization date)+ 1/30.4375. Overall Survival was summarized separately for living participants as only few participants died in this study.
97 66358800 NCT01510184 primary Overall Survival for Death From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years) OS was the time from randomization to death. OS for death calculated as (date of death - randomization date)+ 1/30.4375. Overall Survival was summarized separately for participants who were died as only few participants died in this study.
98 65801015 NCT01536392 primary Percentage of Participants With Response Rate to Anti-Emetic Therapy Days 4-7 Each Chemotherapy Cycle Baseline, up to 7 days post-chemotherapy, through 5 cycles of chemotherapy measured each cycle, an average of 6 weeks Response defined as no emetic or retching episodes and no rescue medication use during late onset phase (4-7 days post-chemotherapy) measured each cycle. Responses tabulated to 4 items of Morisky Medication Adherence measure for each treatment group by cycle of therapy. Elements summarized of Morrow Assessment of Nausea and Emesis and for pill counts/compliance for each treatment group by cycle of therapy. Descriptive statistics summarize total scores for Osoba Module, used to measure effect of nausea and vomiting on quality of life, for each treatment group by cycle of therapy. Osoba Nausea and Emesis Module; higher scores indicate worse quality of life. Morisky Medication Adherence Scale. Higher scores indicate higher compliance. Morisky Medication Adherence Scale is Yes=0 and No=1 , zero is the lowest level of medication adherence, and 4 is the highest level of medication adherence.
99 65800672 NCT01541215 primary Change in HbA1c (Glycosylated Haemoglobin) Week 0, week 26 Change in HbA1c from baseline to week 26. All available data were used for the primary analysis, including data collected after treatment discontinuation and initiation of rescue medication.
100 65798269 NCT01571284 primary Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. A serious AE (SAE): Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs. National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Version 4.03 was used to assess severity (Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling) of AEs.
101 65798270 NCT01571284 primary Number of Participants With Abnormal Hematological Parameters Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) Abnormal hematological parameters included: anaemia, thrombocytopenia, leukopenia and neutropenia. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4 as per NCI CTCAE (Version 4.03), where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.
102 65798271 NCT01571284 primary Number of Participants With International Normalized Ratio (INR) Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) The INR is a derived measure of the prothrombin time. The INR is the ratio of a participant's prothrombin time to a normal control sample. Normal range (without anti coagulation therapy): 0.8-1.2 Targeted range (with anti coagulation therapy) 2.0-3.0.
103 65798272 NCT01571284 primary Number of Participants With Abnormal Electrolytes Parameters Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) Abnormal electrolytes parameters included: hyponatremia, hypernatremia, hypocalcemia, hypercalcemia, hypokalemia, and hyperkalemia. Number of participants with each of these parameters were analyzed by grades ( All Grades and Grades 3-4 as per NCI CTCAE Version 4.03, where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.
104 65798273 NCT01571284 primary Number of Participants With Abnormal Renal and Liver Function Parameters Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) Renal and liver function parameters included: creatinine, hyperbilirubinemia, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4) as per NCI CTCAE version 4.03, where Grade 1=mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.
105 65798274 NCT01571284 primary Creatinine Clearance of Aflibercept Plus FOLFIRI Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) Creatinine clearance is a measure of kidney function. Creatinine clearance rate is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, the creatinine clearance was calculated using the Cockroft-Gault or Modification of Diet in Renal Disease (MDRD).
106 65798275 NCT01571284 primary Number of Participants With Other Abnormal Biochemistry Parameters Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) Other abnormal biochemistry parameters included: hypoglycemia, hyperglycemia and hypoalbuminemia. Number of participants with each of these parameters were analyzed by grades (All Grades and Grades 3-4) as per NCI CTCAE Version 4.03, where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling. All Grades included Grades 1-4.
107 65798276 NCT01571284 primary Number of Participants With Abnormal Non-Gradable Biochemistry Parameters Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) Non-gradeable biochemistry parameters included; chloride, urea, total protein, blood urea nitrogen (BUN) and lactate dehydrogenase (LDH). Number of participants with <lower limit of normal ranges (LLN) and >upper limit of normal ranges (ULN) for each of these parameters were reported.
108 65798277 NCT01571284 primary Number of Participants With Proteinuria Events Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) Proteinuria is defined as the ratio of protein to creatinine. Number of participants with proteinuria were analyzed by grades (Grades 1, 2, 3 ,4) as per NCI CTCAE Version 4.03 where Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening/disabling.
109 65798278 NCT01571284 primary Number of Participants With Proteinuria Grade >=2 Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) Proteinuria is defined as the ratio of protein to creatinine. Number of participants with proteinuria grade >=2 (graded as per NCI CTCAE Version 4.03), where Grade>=2 represents moderate to life-threatening/disabling event.
110 65798279 NCT01571284 primary Number of Participants With Urinary Protein-Creatinine Ratio (UPCR) Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) Urinary protein creatinine ratio (UPCR) corresponds to the ratio of the urinary protein and urinary creatinine concentration (expressed in mg/dL). This ratio provides an accurate quantification of 24-hours urinary protein excretion. There is a high correlation between morning UPCR and 24-hour proteinuria in participants with normal or reduced renal functions. Normal ratio is < or = 1.
111 65798280 NCT01571284 primary Number of Participants With Proteinuria (Grade>=2) Concomitant With Hematuria and /or Hypertension Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) Proteinuria is defined as the presence of excess proteins in the urine (assessed either by spot sample, dipstick/ urine protein or 24 hour urine collection). Hematuria is defined as the presence of blood in urine (positive dipstick for RBC or reported AE). Number of participants with proteinuria grade >=2 (graded as per NCI CTCAE Version 4.03), where Grade>=2 represents moderate to life-threatening/disabling event. Hypertension (high blood pressure) is defined as having a blood pressure reading of more than 140/90 mmHg over a number of weeks.
112 65798281 NCT01571284 primary Number of Participants With Cycle Delay and/or Dose Modification Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) A theoretical cycle is a 2 week period i.e. 14 days. A cycle is delayed if duration of previous cycle is greater than 14+2 days dose modification includes dose reduction and dose omission.
113 65798168 NCT01571362 primary Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12) Weeks 11 and 12 Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain.
114 65798111 NCT01572038 primary Subgroup Analysis by Region of Enrollment: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
115 65798100 NCT01572038 primary Overview of the Number of Participants With at Least One Treatment-Emergent Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v4.0) From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. TEAEs of special interest included LVEF decreased, liver enzymes increased, and suspected transmission of infectious agent by the study drug.
116 65798101 NCT01572038 primary Number of Participants Who Died Over the Course of the Study by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal
117 65798102 NCT01572038 primary Number of Participants Who Died Within 6 Months of Starting Study Treatment by Reported Cause of Death (Adverse Events Leading to Death by System Organ Class and Preferred Term) The median (full range) duration of follow-up was 68.73 (0.03-87.29) months. All adverse events leading to death, regardless of whether they were classified as treatment emergent, are listed by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. Admin. = administration; Mediast. = mediastinal
118 65798103 NCT01572038 primary Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events, Occurring in ≥1% of Participants by System Organ Class and Preferred Term From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs by system organ class (SOC) and preferred term (PT); PTs that are part of a given SOC are listed in the rows directly below each SOC within the results table. If a participant experienced the same AE at more than one severity grade, only the most severe grade was presented.
119 65798104 NCT01572038 primary Number of Participants With Treatment-Emergent Adverse Events of Any Grade That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥10% of Participants by System Organ Class From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the system organ classes are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category.
120 65798105 NCT01572038 primary Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events That Were Related to Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category.
121 65798106 NCT01572038 primary Number of Participants With Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.2% of Participants by Preferred Term From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Discont. = discontinuation; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab
122 65798107 NCT01572038 primary Number of Participants With Treatment-Emergent Adverse Events Leading to Dose Interruption of Study Treatment (Pertuzumab, Trastuzumab, or Taxane), Occurring in ≥0.5% of Participants by Preferred Term From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. MedDRA version 22.1 was used to code AEs and the preferred terms are presented in descending order according to the total frequency of occurrence. If a participant experienced more than one event in a category, they were counted only once in that category. Interrupt. = interruption; Ptz = pertuzumab; Tax = taxane; Trz = trastuzumab
123 65798108 NCT01572038 primary Number of Participants With Treatment-Emergent Adverse Events to Monitor of Any Grade, Occurring in ≥5% of Participants by Category From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; AEs may fall within multiple categories.
124 65798109 NCT01572038 primary Number of Participants With Grade ≥3 Treatment-Emergent Adverse Events to Monitor, Occurring in ≥0.5% of Participants by Category and Preferred Term From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first dose of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, it was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. If a participant had more than one event in a category, they were counted only once in that category. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table.
125 65798110 NCT01572038 primary Number of Participants With Treatment-Emergent Adverse Events of Special Interest by Category and Preferred Term From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs of special interest included LVEF decreased, liver enzymes (ALT or AST) increased, and suspected transmission of infectious agent by the study drug. MedDRA version 22.1 was used to code AEs; preferred terms (PT) that are part of a given category are listed in the rows directly below each category within the results table. If a participant experienced more than one event in a category, they were counted only once in that category.
126 65798112 NCT01572038 primary Subgroup Analysis by Age (≤65 vs. >65 Years): Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent.
127 65798113 NCT01572038 primary Subgroup Analysis by Taxane Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), TEAEs Leading to Death, Grade ≥3 TEAEs, Any-Grade and Grade ≥3 TEAEs Related to Pertuzumab, and TEAEs to Monitor From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. TEAEs to monitor included anaphylaxis and hypersensitivity, cardiac dysfunction, diarrhoea Grade ≥3, pregnancy-related AEs, interstitial lung disease, infusion-/administration-related reactions, mucositis, (febrile) neutropenia, rash/skin reactions, and suspected transmission of infectious agent.
128 65798114 NCT01572038 primary Subgroup Analysis by ECOG Performance Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
129 65798115 NCT01572038 primary Subgroup Analysis by Visceral Disease at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
130 65798116 NCT01572038 primary Subgroup Analysis by Prior (Neo)Adjuvant Chemotherapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
131 65798117 NCT01572038 primary Subgroup Analysis by Hormone Receptor Status at Baseline: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
132 65798118 NCT01572038 primary Subgroup Analysis by Previous Trastuzumab Therapy: Overview of the Number of Participants With Serious Treatment-Emergent Adverse Events (TEAEs), Grade ≥3 TEAEs, and Grade ≥3 TEAEs Related to Pertuzumab From Baseline until 28 days after, or 7 months after (only for serious AEs related to study drug), the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Treatment-emergent adverse events (TEAEs) were adverse events (AEs) that started or worsened in severity on or after the first administration of study drug, up to and including 28 days after the last dose. The investigator graded all AEs for severity per NCI-CTCAE v4.0; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.
133 65798119 NCT01572038 primary Number of Participants With a Congestive Heart Failure Event From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Congestive heart failure was defined as the Standardised MedDRA Query (SMQ) 'Cardiac failure (wide)' from the Medical Dictionary for Regulatory Activities, version 22.1 (MedDRA version 22.1).
134 65798120 NCT01572038 primary Time to Onset of the First Episode of Congestive Heart Failure From Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Congestive heart failure was defined as SMQ 'Cardiac failure (wide)' from the MedDRA version 22.1. Time to onset of the first episode of congestive heart failure was analyzed using a Kaplan-Meier approach. Participants who did not experience any congestive heart failure at the time of data-cut were censored at the date of the last attended visit whilst on-treatment (including visits up to and including 28 days after last dose of study treatment). Only treatment emergent congestive heart failure events are included.
135 65798121 NCT01572038 primary Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. All participants must have had a baseline LVEF ≥50% to enroll in the study; patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The change from baseline LVEF values were reported at every 3 cycles over the course of the study and at the final treatment, worst treatment, and maximum decrease values. The final treatment value was defined as the last LVEF value observed before all study treatment discontinuation. The worst treatment value was defined as the lowest LVEF value observed before all study treatment discontinuation. The maximum decrease value was defined as the largest decrease of LVEF value from baseline, or minimum increase if a participant's post-baseline LVEF measures were all larger than the baseline value.
136 65798122 NCT01572038 primary Number of Participants by Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Categories Over the Course of the Study Baseline, predose on Day 1 of every 3 cycles (1 cycle is 3 weeks) during treatment period, and 28 days post-treatment safety follow-up. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. All participants must have had a baseline LVEF greater than or equal to (≥)50% to enroll in the study patients with significant cardiac disease or baseline LVEF below 50% were not eligible for this study. The number of participants are reported according to four change from baseline in LVEF value categories over the course of the study: 1) an increase or decrease from baseline LVEF less than (<)10% points or no change in LVEF 2) an absolute LVEF value <45% points and a decrease from baseline LVEF ≥10% points to <15% points 3) an absolute LVEF value <45% points and a decrease from baseline LVEF ≥15% points or 4) an absolute LVEF value ≥45% points and a decrease from baseline LVEF ≥10% points. BL = baseline Decr. = decrease Incr. = increase
137 65798123 NCT01572038 primary Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.
138 65798124 NCT01572038 primary Number of Participants With Laboratory Abnormalities in Hematology and Coagulation Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Clinical laboratory tests for hematology and coagulation parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.
139 65798125 NCT01572038 primary Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to NCI-CTC v4.0 Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on NCI-CTC v4.0 from Grades 1 (least severe) to 4 (most severe). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.
140 65798126 NCT01572038 primary Number of Participants With Laboratory Abnormalities in Biochemistry Parameters: Shift From Baseline to the Worst Post-Baseline Grade According to Normal Range Criteria Predose at each treatment cycle (1 cycle is 3 weeks) from Baseline until 28 days after the last dose of study treatment. The median (full range) duration of exposure to any study treatment was 16.2 (0.0-86.4) months. Clinical laboratory tests for biochemistry parameters were performed at local laboratories. Laboratory toxicities were defined based on local laboratory normal ranges (for parameters with NCI-CTC grade not defined). Some laboratory parameters are bi-dimensional (i.e. can be graded in both the low and high direction). These parameters were split and presented in both directions. Baseline was defined as the last non-missing measurement taken prior to the first dose of study treatment (including unscheduled assessments). Values from all visits, including unscheduled visits, were included in the derivation of the worst post-baseline grade. Not every abnormal laboratory value qualified as an adverse event, only if it met any of the following criteria: was clinically significant (per investigator); was accompanied by clinical symptoms; resulted in a change in study treatment; or resulted in a medical intervention or a change in concomitant therapy.
141 65797515 NCT01578499 primary Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4) Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months) ORR4 was determined by an Independent Review Facility (IRF) based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic assessment by an IRF and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Participants whose first response occurred after the start of subsequent anticancer therapy were excluded. Response Criteria was based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and Cutaneous Lymphoma Task Force (CLTF) of the European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines (Olsen, 2011).
142 65795896 NCT01597908 primary Overall Survival (OS) From the date of randomization until date of death due to any cause (up to approximately 6 years) Overall Survival (OS) was defined as the interval of time between the date of randomization and the date of death due to any cause. For patients who did not die, OS was censored at the date of last contact.
143 65794590 NCT01610284 primary Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to approximately 4 years Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm.
144 65792502 NCT01633060 primary Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS) Every 6 weeks after randomization up to a maximum of 4 years Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm. Patients were followed up for approximately every 6 weeks after randomization.
145 65791562 NCT01642004 primary Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint Randomization until 199 deaths, up to November 2014, approximately 25 months OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.
146 65791563 NCT01642004 primary Overall Survival (OS) Rate in All Randomized Participants Randomization to 18 months post-randomization, up to June 2015 The overall survival rate is the probability that a participant will be alive at 6, 12, and 18 months following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.
147 65791564 NCT01642004 primary Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint Randomization until 199 deaths, up to November 2014, approximately 25 months The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.
148 65791148 NCT01646021 primary Progression Free Survival (PFS) Time from the date of randomization until the date of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death, whichever occurred first (approximately 48 months) PFS is defined as the duration in months from the date of randomization to the date of progression disease (PD) or relapse from complete response (CR) or death whichever was reported first and was assessed based on the investigator assessment. Revised Response Criteria for Malignant Lymphoma categorizes the response of the treatment of a patient's tumour to CR (the disappearance of all evidence of disease), Relapsed Disease or PD (Any new lesion or increase by greater than or equal to [>=] 50 percent [%] of previously involved sites from nadir).
149 65789596 NCT01663623 primary Time to First Relapse Approximately up to 4 years Time to relapse is defined as the number of days from Day 0 until the participant experienced a relapse (relapse date - treatment start date +1). Only post-baseline relapses were considered in these analyses. Only relapses occurring up to and including the last visit date in the double-blind treatment period were considered in these analyses. Intent-to-treat population comprised of all randomized participants who received at least one dose of study agent (belimumab or placebo). NA indicates that the data was not available as the Number of events is too low to estimate the value. Median and Inter-quartile range were presented and were based on Kaplan Meier estimates.
150 64158296 NCT01673867 primary Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint Randomization until 413 deaths, up to March 2015 (approximately 29 months) OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.
151 64158297 NCT01673867 primary One-year Overall Survival (OS) Rate in All Randomized Participants 12 months The one-year overall survival rate is a percentage, representing the fraction of all randomized participants who were alive following one year of treatment. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.
152 64158298 NCT01673867 primary Number of Deaths From Any Cause in All Randomized Participants at Primary Endpoint Randomization until 413 deaths, up to March 2015 (approximately 29 months) The number of participants who died from any cause was reported for each arm. Interim analysis (Primary Endpoint) was planned to occur after at least 380 deaths, with the actual analysis occurring at 413 deaths.
153 65784565 NCT01713946 primary Core Phase: European Medicine Agency (EMA): Seizure Frequency Response Rate Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase) Comparison of response rates in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm. Response means at least a 50% reduction from baseline in partial-onset seizure frequency during the maintenance period of the core phase.
154 65784566 NCT01713946 primary Core Phase: Food & Drug Administration (FDA): Percentage Change From Baseline in Partial Onset-seizure Frequency Baseline (8-week period before randomization), Week 7 to 18 (12-week maintenance period of the core phase) Comparison of median percent change from baseline in weekly seizure frequency in the everolimus low-trough treatment arm (3-7 ng/mL), high-trough treatment arm (9-15 ng/mL) and placebo arm during maintenance period of the core phase. Percentage change from baseline in average weekly seizure frequency during the maintenance period of the Core phase (SFcfb) = 100 × (SFB - SFM) ÷ SFB where: SFB is the average weekly seizure frequency in the Baseline phase SFM is the average weekly seizure frequency in the maintenance period of the Core phase A positive percentage change from baseline (SFcfb) means a reduction in seizure frequency whereas a negative percentage change from baseline (SFcfb) means an increase in seizure frequency.
155 65783857 NCT01721772 primary Overall Survival (OS) From date of randomization to date of death. For those without documentation of death, to the last date the participant was known to be alive, assessed up to 17 months. OS is defined as the time between the date of randomization and the date of death or the last date the participant was known to be alive.
156 65783858 NCT01721772 primary Overall Survival (OS) Rate From randomization to 6 months and or to 12 months OS rate is calculated as the percentage of participants alive at the indicated timepoints
157 65782873 NCT01732913 primary Progression Free Survival Progression-free survival (PFS) is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphoma (iNHL) disease progression or death from any cause. PFS was to be assessed by an independent review committee (IRC).
158 65782868 NCT01732926 primary Progression-free Survival (PFS) PFS is defined as the interval from randomization to the earlier of the first documentation of definitive indolent non-Hodgkin lymphomas (iNHL) disease progression or death from any cause. Definitive iNHL disease progression is progression based on standard criteria. PFS was to be assessed by an independent review committee (IRC).
159 65781700 NCT01747915 primary Log-transformed (Log) 28-day Seizure Rate for All Primary Generalized Tonic-Clonic (PGTC) Seizures During 12-Week Double-Blind Treatment Phase Day 1 up to Week 12 All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1).
160 65780474 NCT01764841 primary Time to First Exacerbation Event Within 48 Weeks Up to Week 48 Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.
161 65776795 NCT01808118 primary Number of Participants Who Did Not Experience a Flare During Period 2 by Week 68 From Week 28 through 68 The Ankylosing Spondylitis Disease Activity Score (ASDAS) tool is a self-administered questionnaire/objective laboratory evaluation. The questionnaire assesses disease activity, back pain, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and duration of morning stiffness on a numeric rating scale (from 0 to 10, with 0 being none and 10 representing a duration of ≥2 hours). The laboratory parameter is a measurement of high-sensitivity C-reactive protein (mg/L) (hs-CRP). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and hs-CRP) are combined to yield a score (0 to no defined upper limit). During Period 2 participants visited study sites at Weeks 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and 68 or if they discontinued early from the study. A flare was defined as having any 2 consecutive study visits with ASDAS ≥ 2.100.
162 65776714 NCT01808573 primary Centrally Assessed Progression Free Survival From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut. Progression Free Survival (PFS), Measured in Months, for Randomized Subjects of the Central Assessment. The time interval from the date of randomization until the first date on which recurrence, progression (per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1), or death due to any cause, is documented. For subjects without recurrence, progression or death, it is censored at the last valid tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 24 months.
163 65776715 NCT01808573 primary Overall Survival From randomization date to death, assessed up to 59 months.The result is based on primary analysis data cut. Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 48 months.
164 65775940 NCT01819129 primary Change From Baseline in HbA1c Week 0, Week 26 The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.
165 65772551 NCT01866319 primary Progression-free Survival (PFS) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Radiology Plus Oncology Review (IRO) Up to approximately 12 months (through first pre-specified statistical analysis cut-off date of 03-Sep-2014) PFS was defined as the time from randomization to the first documented disease progression, based on blinded Independent Radiology plus Oncology review (IRO) using RECIST 1.1, or death due to any cause, whichever occurred first. Disease progression was defined as a 20% or greater increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of new lesions. The primary analysis of PFS was performed at the time of the first protocol pre-specified statistical analysis, with data cut-off of 03-Sep-2014.
166 65772552 NCT01866319 primary Percentage of Participants With Overall Survival (OS) at 12 Months Month 12 OS was defined as the time from randomization to death due to any cause. The percentage of participants with OS (OS rate) at 12 months was reported for each arm. The reported percentage was estimated using a product-limit (Kaplan-Meier) method for censored data; data were censored at the date of cut-off. The primary analysis of OS was performed at the time of the second protocol pre-specified statistical analysis, with data cut-off of 03-Mar-2015.
167 65770619 NCT01891890 primary Conners' Continuous Performance Test II (CPT-II) Confidence Index Baseline, Month 6 The Conners' Continuous Performance Test II (CPT-II) is a measure of sustained attention. Letters are individually presented on a computer screen, and participants are instructed to press the space bar when they are presented with any letter except the letter "X". For children younger than 6 years of age at enrollment, the Kiddie CPT will be used in which the child is instructed to press the space bar every time the ball appears on the screen. The outcome measure is a confidence index representing the probability that the respondent has a clinically relevant problem in sustained attention. Possible scores range from 0 to 100. Scores between 40 and 60 are considered inconclusive while scores above 60 indicate that the child exhibits inattentiveness.
168 65769554 NCT01905592 primary Progression Free Survival (PFS) - Central Review Assessment From the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier, up to 4 years The primary objective of this study is to compare progression-free survival (PFS), as assessed by blinded central review, of participants with advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative gBRCA mutation breast cancer when treated with niraparib as compared to those treated with physician's choice single agent chemotherapy standards (eribulin, vinorelbine, gemcitabine or capecitabine). PFS is defined as the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier as per Response evaluation criteria in solid tumors (RECIST) version (v)1.1 as determined by central review assessment. Progressive Disease is defined as at least a 20 percent (%) increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of >= 5 millimeter (mm).
169 65769319 NCT01908829 primary Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours Baseline and end of treatment (up to 12 weeks) The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary & at least 1 micturition postbaseline & reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable.
170 65768317 NCT01920477 primary Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy Baseline up to approximately 60 weeks Sustained remission = time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to <=10 mg/day and maintenance of a dose <=10 mg/day with no new or nonhealing lesions for >=8 weeks and maintenance of the status until Week 60.
171 65768318 NCT01920477 primary Duration of Remission on Minimal Steroid Therapy Baseline up to approximately 60 weeks Sum of all periods of absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of <=10 mg/day up to Week 60 was assessed.
172 65768118 NCT01922011 primary Percentage of Participants With Clinical Improvement in the 3 General Categories of Pain, Inflammation, and Limb Function Based on the Investigator's Overall Assessment of Severity of Each of the Symptom Categories. Up to study Day 5 Clinical improvement was based on the Investigator's overall assessment of severity of each of the 3 general symptom categories of Pain, Inflammation, and Limb Function. Based on this evaluation, a participant was considered to have met criteria for clinical improvement according to the following definition: If 3 general categories are present at baseline: at least a 1-point improvement (i.e. severe to moderate, moderate to mild, mild to absent) in at least 2 of the general categories and no worsening in the other. If 2 general categories are present at baseline: at least a 2-point improvement (i.e. severe to mild, moderate to absent) in at least 1 of the general categories and no worsening or new findings in the others OR at least a 1-point improvement in both and no new findings in the other. If 1 general category is present at baseline: at least a 2-point improvement (i.e., severe to mild, moderate to absent) in that category and no new findings in the others.
173 65765979 NCT01940497 primary Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Day 1 up to 28 days after last dose of trastuzumab (up to approximately 1 year) An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were the AEs occurring from starting on the day of or after first administration of trastuzumab and within 28 days after last dose of trastuzumab. Data for this outcome measure were analyzed and reported by adjuvant versus neoadjuvant chemotherapy groups within each treatment arm.
174 65764383 NCT01958671 primary Change From Baseline In A1C at Week 26 Baseline and Week 26 A1C is measured as percent. The change from baseline is the Week 26 A1C percent minus the Week 0 A1C percent. Laboratory measurements were performed after an overnight fast ≥10 hours in duration. Data presented exclude data following the initiation of rescue therapy.
175 65764384 NCT01958671 primary Percentage of Participants Experiencing An Adverse Event (AE) Up to 54 weeks (including 2 weeks following last dose) An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.
176 65764385 NCT01958671 primary Percentage of Participants Discontinuing Study Treatment Due to an AE Up to 52 weeks An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Data presented include data following the initiation of rescue therapy.
177 65764000 NCT01962441 primary Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) Posttreatment Week 12 SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
178 65764001 NCT01962441 primary Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event Up to 24 weeks
179 65763600 NCT01967940 primary Part 1: Percentage of Participants With Plasma HIV-1 RNA Decreases From Baseline Exceeding 0.5 log10 at Day 10 Day 10
180 65762716 NCT01976364 primary Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death initial or prolonged inpatient hospitalization life-threatening experience (immediate risk of dying) persistent or significant disability/incapacity congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 48 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.
181 65762717 NCT01976364 primary Number of Adverse Events (AEs) by Severity Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified into 3 categories according to their severity as mild AEs (did not interfere with participant's usual function), moderate AEs (interfered to some extent with participant's usual function) and severe AEs (interfered significantly with participant's usual function).
182 65762718 NCT01976364 primary Number of Participants With Abnormal Clinical Laboratory Values Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study) Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes,neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin [total, direct, indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids (cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy (urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Laboratory abnormality: determined by investigator per pre-defined criteria.
183 65762719 NCT01976364 primary Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study) Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin[total,direct,indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids(cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine-pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy(urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Clinically significant change: determined by investigator per pre-defined criteria.
184 65762720 NCT01976364 primary Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6 Sub-study: Baseline (Day 1), Month 6 HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score ranged from 0 (least difficulty) to 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.
185 65762721 NCT01976364 primary Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6 Sub-study: Baseline (Day 1), Month 6 PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in millimeter (mm), swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), short form-36 questionnaire (SF-36) physical component summary (norm-based domain scores were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.
186 65761723 NCT01987479 primary Percentage of Participants With Adverse Events Baseline up to Week 32 An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events included serious as well as non-serious adverse events.
187 65761714 NCT01987505 primary Percentage of Participants With Administration-Associated Reactions (AARs) From start of treatment to end of treatment (up to 32 months) AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
188 65760039 NCT02008227 primary Percentage of Participants Who Died: PP-ITT Baseline until death due to any cause (up to approximately 2.25 years)
189 65760040 NCT02008227 primary Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP Baseline until death due to any cause (up to approximately 2.25 years) Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in >/=1% and <5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in >/=5% and <50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in >/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=1% and <5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=5% and <10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering >/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma.
190 65760041 NCT02008227 primary Overall Survival (OS): PP-ITT Baseline until death due to any cause (up to approximately 2.25 years) OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
191 65760042 NCT02008227 primary OS: TC1/2/3 or IC1/2/3 Subgroup of PP Baseline until death due to any cause (up to approximately 2.25 years) OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
192 65760043 NCT02008227 primary OS: SP-ITT Baseline until death due to any cause (up to approximately 2.87 years) OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
193 65760044 NCT02008227 primary OS: TC1/2/3 Or IC1/2/3 Subgroup of SP Baseline until death from any cause (approximately 2.87 years) OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
194 65760045 NCT02008227 primary OS: TC2/3 or IC2/3 Subgroup of SP Baseline until death due to any cause (up to approximately 2.87 years) OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
195 65760046 NCT02008227 primary OS: TC3 or IC3 Subgroup of SP Baseline until death due to any cause (up to approximately 2.87 years) OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
196 65759081 NCT02019420 primary Number of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population Up to 28 days The numbers of participants with all-cause mortality within 28 days after randomization was determined in the ITT population. Any participants who were lost to follow-up and not known to be alive or deceased by Day 28 were imputed as deceased.
197 64619564 NCT02032277 primary Pathological Complete Response (pCR). At the time of definitive surgery (approximately 24-36 weeks from first dose of study drug). Pathological complete response (pCR) in the breast tissue and the lymph node tissue will be assessed upon completion of pre-operative systemic therapy and definitive surgery.
198 65757541 NCT02038920 primary Induction Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response Week 10 A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
199 65757542 NCT02038920 primary Maintenance Phase: Percentage of Participants With Clinical Remission Week 60 Clinical remission is defined as the CDAI score ≤150. CDAI is scoring system for the assessment of Crohn's disease activity. Index values of 150 and below are associated with quiescent disease values above that indicate active disease.
200 65757543 NCT02038920 primary Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs) From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) An Adverse event (AE) is defined as any untoward medical occurrence in a study participant who received a drug (including a study drug); it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
201 65757544 NCT02038920 primary Number of Participants With TEAE Related to Body Weight (Weight Decreased) From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) Reported events on this outcome measure were "Weight Decreased".
202 65757545 NCT02038920 primary Number of Participants With TEAE Related to Vital Signs From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) Vital signs included body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). Reported events on this outcome measure were "Pyrexia", "Body temperature increased", "Hypertension", and "Orthostatic hypotension".
203 65757546 NCT02038920 primary Number of Participants With TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right] From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) Reported events on this outcome measure were "Bundle Branch Block Right".
204 65757547 NCT02038920 primary Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) The laboratory values outside the range (Hemoglobin <=7 g/dL, Lymphocytes <500 /microL, White Blood Cell (WBC) <2000 /microL, Platelets <7.5 10^4/microL, Neutrophils <1000 /microL, Alanine Aminotransferase (ALT) (Glutamic Pyruvic Transaminase; GPT) >3.0 U/L x upper limit of normal (ULN), Aspartate Aminotransferase (AST) (Glutamic Oxaloacetic Transaminase; GOT) >3.0 U/L x ULN, Total Bilirubin >2.0 mg/dL x ULN, Amylase >2.0 (U/L) x ULN are considered markedly abnormal.
205 65757473 NCT02039505 primary Percentage of Participants With a Clinical Response at Week 10 in Induction Phase Week 10 Clinical response is defined as a reduction in complete Mayo score of ≥3 points and ≥30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores (rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment), a global assessment by the physician, and an endoscopic subscore. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
206 65757474 NCT02039505 primary Percentage of Participants With Clinical Remission at Week 60 in Maintenance Phase Week 60 Clinical Remission is defined as a complete Mayo score of ≤2 points and no individual subscore >1 point. Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 subscores: rectal bleeding, stool frequency, findings on endoscopy, and physician's global assessment. Each subscore is scored on a scale from 0 to 3 and the complete Mayo score ranges from 0 to 12 (higher scores indicate greater disease activity).
207 65757475 NCT02039505 primary Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs) From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
208 65757476 NCT02039505 primary Number of Participants With TEAE Related to Body Weight From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)
209 65757477 NCT02039505 primary Number of Participants With TEAE Related to Vital Signs From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) Vital signs included body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).
210 65757478 NCT02039505 primary Number of Participants With TEAE Related to Electrocardiogram (ECG) From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)
211 65757479 NCT02039505 primary Number of Participants With Markedly Abnormal Laboratory Parameters Values From Baseline to 16 weeks after the last dose of study drug (Up to approximately 170 weeks) The laboratory values outside the range (Hemoglobin <=7 g/dL, Lymphocytes <500 /µL, WBC <2000 /µL, Platelets <7.5 10^4/µL, Neutrophils <1000 /µL, alanine aminotransferase (ALT) >3.0 U/L x upper limit of normal (ULN), aspartate aminotransferase (AST) >3.0 U/L x ULN, Total Bilirubin >2.0 mg/dL x ULN, Amylase >2.0 (U/L) x ULN were considered markedly abnormal. Only laboratory parameters with events were represented.
212 65757314 NCT02042183 primary Number of Participants Classified as Overall Responders at Week 12 at Week 12 An overall responder is defined as a participant who qualified as a weekly responder for 9 of the 12 treatment weeks, with durability demonstrated by at least 3 of the responder weeks occurring during the last 4 weeks of the treatment period. A weekly responder is defined as a participant who has at least 3 spontaneous bowel movements during the week, and at least one more than at baseline.
213 65756716 NCT02052310 primary US (FDA) Submission: Mean Hb Change From Baseline to The Average Level During The Evaluation Period (Week 28 to Week 52), Regardless of Rescue Therapy (ITT Population) Baseline (Day 1, Week 0), Week 28 to 52 Hb values under the influence of rescue therapy were not censored for the primary analysis. Rescue therapy for roxadustat treated participants was defined as recombinant erythropoietin or analogue (erythropoiesis-stimulating agent [ESA]) or red blood cell (RBC) transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion. Baseline Hb was defined the mean of up to 4 last central lab values prior to the first dose of study treatment. The intermittent missing Hb data was imputed for each treatment relying on non-missing data from all participants within each treatment group using the Monte Carlo Markov Chain (MCMC) imputation model, Monotone missing data were imputed by regression from its own treatment group.
214 65756717 NCT02052310 primary Ex-U.S. Submission: Hb Responder Rate- Percentage of Participants Who Achieved a Hb Response at 2 Consecutive Visits at Least 5 Days Apart During First 24 Weeks of Treatment, Without Rescue Therapy Within 6 Weeks Prior to the Hb Response (PPS Population) Baseline (Day 1, Week 0) up to Week 24 Hb response was defined, using central laboratory values, as: Hb ≥11.0 g/dL and a Hb increase from baseline by ≥1.0 g/dL in participants whose baseline Hb >8.0 g/dL, or increase in Hb ≥2.0 g/dL in participants whose baseline Hb ≤8.0 g/dL. Rescue therapy for roxadustat treated participant was defined as recombinant erythropoietin or analogue (ESA) or RBC transfusion, and rescue therapy for epoetin alfa treated participants was defined as RBC transfusion.
215 65755648 NCT02065557 primary Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period Week 8 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 sub scores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in PMS indicates improvement. Clinical remission was defined as a PMS ≤ 2 and no individual subscore > 1.
216 65755649 NCT02065557 primary Co-Primary Endpoint 2: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 52 in Week 8 Responders Per PMS - Maintenance Period Week 52 The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
217 65755630 NCT02065570 primary Percentage of Participants Who Achieved Clinical Remission at Week 4 Week 4 Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
218 65755631 NCT02065570 primary Percentage of Participants With Endoscopic Response at Week 12 Week 12 Endoscopic response was scored using the Simplified Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD total score > 50% from Baseline (or for a Baseline SES-CD of 4, at least a 2 point reduction from Baseline) at Week 12.
219 65755632 NCT02065570 primary Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks). Adverse event (AE): any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. Serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. TEAEs: any event that began or worsened in severity after the first dose of study drug in the induction or maintenance study. Events with unknown severity were counted as severe. Events with unknown relationship to study drug were counted as drug-related.
220 65755607 NCT02065622 primary Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8 Week 8 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
221 65755608 NCT02065622 primary Maintenance Period Primary Endpoint: Percentage of Week 8 Responders (Per FMS) With Clinical Remission (Per FMS) at Week 52 Week 52 The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per FMS) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease from baseline in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
222 66112997 NCT02066636 primary The Number of Participants With Treatment Related Select Adverse Events (Grade 3-4 and Grade 5) From first dose and 100 days after last dose (last dose up to randomization for cohort B) (up to approximately 88 months) A treatment related adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered an investigational (medicinal) product and that has a causal relationship with this treatment. The select AEs categories are those that are expected to be most commonly used to describe pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, and endocrinopathies and hypersensitivity/infusion reactions. AEs are graded according to NCI CTCAE (Version 4.0) guidelines where Grade 3= Severe, Grade 4 = Life-threatening, Grade 5 = Death.
223 65755285 NCT02070757 primary Percentage of Participants With All Cause Mortality in the Intent-to-Treat (ITT) Population - Day 28 Day 28 To demonstrate the non-inferiority of ceftolozane/tazobactam versus meropenem in stratified adult participants with ventilated nosocomial pneumonia (VNP) (participants with either ventilator-associated bacterial pneumonia [VABP] or ventilated hospital-acquired bacterial pneumonia [HABP]) based on the difference in all-cause mortality rates in the intent to treat (ITT) population using a non-inferiority margin of 10%. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.
224 65755116 NCT02072824 primary Log Transformed 24-Hour Seizure Rate for All Partial Onset Seizures During the Double-Blind Treatment Phase Day 1 up to Day 14 All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible "0" seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1).
225 65755005 NCT02074982 primary Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 Week 16 Psoriasis Area and Severity Index (PASI) is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72(maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4). PASI 90 responders were defined as participants achieving ≥ 90% improvement at Week 16
226 65753127 NCT02099110 primary Change From Baseline in A1C at Week 26: Excluding Rescue Approach Baseline and Week 26 A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 26 A1C minus the Week 0 A1C. Excluding recue approach data analysis excluded all data following the initiation of rescue therapy at any time point, in order to avoid the confounding influence of the rescue therapy.
227 65753128 NCT02099110 primary Percentage of Participants Who Experienced an Adverse Event (AE): Including Rescue Approach Up to 54 weeks An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy.
228 65753129 NCT02099110 primary Percentage of Participants Who Discontinued Study Treatment Due to an AE: Including Rescue Approach Up to 52 weeks An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Including rescue approach data analysis included data following the initiation of rescue therapy.
229 65752712 NCT02105636 primary Overall Survival (OS) From date of randomization to date of death (Up to approximately 18 months) OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method.
230 64619059 NCT02106546 primary Overall Survival (OS) in current smokers Up to 3 years from first dose of study drug Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.
231 65752557 NCT02106832 primary Time to First Exacerbation Event Within 48 Weeks - Cipro 28 vs. Pooled Placebo Up to Week 48 Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.
232 65752558 NCT02106832 primary Time to First Exacerbation Event Within 48 Weeks - Cipro 14 vs. Pooled Placebo Up to Week 48 Time to first exacerbation was defined as the time from randomization until the visit at which the first qualifying exacerbation is recorded by the investigator. Exacerbation events are defined as exacerbations with systemic antibiotic use and presence of fever or malaise / fatigue and worsening of at least three signs/symptoms.
233 65750571 NCT02130557 primary Percentage of Participants With Major Molecular Response (MMR) at Month 12 Month 12 MMR was defined as a ratio of breakpoint cluster region to abelson (BCR-ABL/ABL) less than or equal to (<=) 0.1 percent (%) on the international scale (IS) (greater than or equal to [>=] 3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts [>=3000 ABL required]) by quantitative reverse transcriptase polymerase chain reaction (RT-qPCR). The percentage of participants with MMR at Month 12 are reported.
234 65750511 NCT02131233 primary Percentage of Participants Achieving <40 Copies/mL Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) at Week 48 Week 48 From blood samples collected at week 48, HIV-1 RNA levels were determined by the Abbott RealTime HIV-1 Assay, which has a limit of reliable quantification (LoQ) of 40 copies/mL. The NC=F approach as defined by FDA "snapshot" approach was used as the primary approach to analysis where all missing data were treated as failures regardless of the reason.
235 66342088 NCT02136069 primary Percentage of Participants With Both Clinical Response at Week 10 and Clinical Remission at Week 54, as Determined by the Mayo Clinic Score (MCS) Week 10, Week 54 Mayo Clinic Score (MCS) is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease. Clinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1. Clinical Remission is MCS ≤2 with individual subscores ≤1.
236 65750053 NCT02138136 primary Median Number of Observed Weekly Spontaneous Bowel Movements (SBM) Per Month within 9 months Spontaneous bowel movements are defined as bowel movements without the aid of drugs.
237 64198800 NCT02142738 primary Progression Free Survival (PFS) Rate at Month 6 Month 6 PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment. The data cutoff was 09-May-2016. The PFS rate at Month 6 was calculated.
238 65749378 NCT02147158 primary Percentage of Participants With Absence of Bleeding During the Last 35 Consecutive Days on Treatment in Treatment Course 1 Last 35 consecutive days on treatment in the 12-Week Treatment Course 1 Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 1.
239 65749379 NCT02147158 primary Time to Absence of Bleeding on Treatment During Treatment Course 1 From first dose up to the end of the 12-Week Treatment Course 1 Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the first treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 1.
240 66358764 NCT02149121 primary Analysis of Serum AUC0-last of Rituximab During the 1st Course of the Main Study Period (Over the First 24 Weeks) (ANCOVA) over the first 24 weeks For evaluation of pharmacokinetics (PK), the primary endpoint was defined as the analysis of serum AUC0-last, AUC0-inf and Cmax of rituximab during the 1st course of the Main Study Period (over the first 24 weeks). During the 1st course of the Main Study Period, blood samples for PK analysis were collected every week from Week 0 to Week 4, every 4 weeks from Week 4 to Week 16, followed by Week 24. AUC0-last: Area under the concentration-time curve from time to the last measurable concentration over both doses of the 1st course
241 66358765 NCT02149121 primary Analysis of Serum AUC0-inf of Rituximab During the 1st Course of the Main Study Period (Over the First 24 Weeks) (ANCOVA) at Week 24 of the Main Study Period For evaluation of PK, the primary endpoint was defined as the analysis of serum AUC0-last, AUC0-inf and Cmax of rituximab during the 1st course of the Main Study Period (over the first 24 weeks). During the 1st course of the Main Study Period, blood samples for PK analysis were collected every week from Week 0 to Week 4, every 4 weeks from Week 4 to Week 16, followed by Week 24. AUC0-inf: Area under the concentration-time curve from time 0 extrapolated to infinity over both doses of the 1st course
242 66358766 NCT02149121 primary Analysis of Serum Cmax of Rituximab During the 1st Course of the Main Study Period (Over the First 24 Weeks) (ANCOVA) at Week 24 of the Main Study Period For evaluation of pharmacokinetics (PK), the primary endpoint was defined as the analysis of serum AUC0-last, AUC0-inf and Cmax of rituximab during the 1st course of the Main Study Period (over the first 24 weeks). During the 1st course of the Main Study Period, blood samples for PK analysis were collected every week from Week 0 to Week 4, every 4 weeks from Week 4 to Week 16, followed by Week 24. Cmax: Observed maximum concentration after the seocnd infusion of the 1st course
243 66358767 NCT02149121 primary Analysis of Change From Baseline of DAS28 (CRP) at Week 24 (ANCOVA) at Week 24 of the Main Study Period For evaluation of efficacy, the primary endpoint was defined as the analysis of change from baseline in disease activity measured by disease activity score 28 (DAS 28) C-reactive protein (CRP) at Week 24 between 2 treatment groups, CT-P10 and reference products (combined Rituxan and MabThera) groups. During the 1st course of the Main Study Period, DAS28 was assessed every 4 weeks from Week 0 to Week 24. DAS28 (CRP) was calculated using the following formula: DAS28 (CRP) = 0.56 X SQRT(TJC28) + 0.28 X SQRT(SJC28) + 0.36 X ln(CRP+1) + 0.014 X GH on VAS + 0.96. DAS28 (CRP) provides a number on a scale from 0 to 10 with higher values indicating greater RA disease activity.
244 65748508 NCT02158936 primary Number of Participants Who Were Platelet Transfusion Independent During Cycles 1-4 of Azacitidine Therapy 4 cycles (Cycle = 28 days) A subject is defined as being platelet transfusion independent if they received no platelet transfusions within the first 4 cycles of treatment with azacitidine. Subjects who died or withdrew from investigational product within the first four cycles were treated as failures (i.e. not transfusion independent) in the analysis
245 65748242 NCT02162771 primary Area Under the Serum Concentration-time Curve at Steady State (AUCtau) Core Cycle 4 (Week 12) AUCtau: Area under the plasma drug concentration-time curve within a dosing interval at steady state. PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained.
246 65748243 NCT02162771 primary Maximum Serum Concentration at Steady State (Cmax,ss) Core Cycle 4 (Week 12) Cmax,ss: Maximum concentration of drug in plasma at steady state on administering a fixed dose at equal dosing intervals. PK sampling was done at pre-dose and 1 hour after the end of infusion (EOI) at Core Cycles 1-3 and 5-8. At Core Cycle 4 (i.e. steady state), intensive PK samplings were done as follows: predose, EOI, 1 hour after EOI, 24 hour after EOI, 168 hour after EOI, 336 hour after EOI, 504 hour after EOI. Lastly, one sample at any time of the end of treatment (EOT) 1 visit was obtained.
247 65748244 NCT02162771 primary Overall Response Rate (ORR) According to the 1999 International Working Group (IWG) Criteria During the Core Study Period (up to 8 cycles Week 24) ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed complete response (CRu), or partial response (PR) by central review. Per 1999 IWG criteria, the disease status was assessed by using contrasted CT, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: >=75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: >=50% decrease in SPD of target lesions and no evidence of disease progression.
248 65748156 NCT02163759 primary Percentage of Participants in Remission at Week 10 With Etrolizumab as Compared With Placebo, as Determined by the Mayo Clinic Score (MCS), GA28948 Population Week 10 The Mayo Clinic Score (MCS) ranges from 0 to 12 and is a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease. Remission was defined as MCS less than or equal to (≤)2 with individual subscores ≤1 and a rectal bleeding subscore of 0. Participants were also classified as non-remitters if Week 10 assessments were missing or if they had received permitted/prohibited rescue therapy prior to assessment. Participants were stratified by concomitant treatment with corticosteroids or immunosuppressants at randomization and disease activity measured during screening (MCS ≤9/MCS ≥10); the Cochran-Mantel-Haenszel test adjusted the difference in remission rates and associated 95% confidence interval for the stratification factors.
249 65748049 NCT02165397 primary Progression Free Survival (PFS) Based on Independent Review Committee (IRC) Assessment - Kaplan Meier Landmark Estimates at Month 54 Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr]) PFS was defined as the time from date randomization to date of first IRC-confirmed disease progression (PD) assessed according to the modified VIth International Workshop on Waldenström's Macroglobulinemia (IWWM) criteria (National Comprehensive Cancer Network [NCCN] 2014) or death due to any cause, whichever occurs first, regardless of the use of subsequent antineoplastic therapy prior to documented PD or death. As the median PFS was not reached in the Ibrutinib + Rituximab arm at the time of the analysis, Kaplan Meier landmark estimate of the PFS rate at 54 months (that is, the estimated percentage of participants with PFS at Month 54) is presented.
250 64455249 NCT02167945 primary All-Cause Death: Time to Event At Post-Treatment Weeks 52, 104, 156, 208, and 260 Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
251 64455250 NCT02167945 primary Liver-Related Death: Time to Event At Post-Treatment Weeks 52, 104, 156, 208, and 260 Time to liver-related death was defined as number of days from the 1st day of study drug dosing for the participant to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
252 64455251 NCT02167945 primary Liver Decompensation: Time to Event At Post-Treatment Weeks 52, 104, 156, 208, and 260 Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
253 64455252 NCT02167945 primary Liver Transplantation: Time to Event At Post-Treatment Weeks 52, 104, 156, 208, and 260 Time to liver transplantation was defined as number of days from the 1st day of study drug dosing for the participant to date of liver transplantation. All liver transplantation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
254 64455253 NCT02167945 primary Hepatocellular Carcinoma: Time to Event At Post-Treatment Weeks 52, 104, 156, 208, and 260 Time to hepatocellular carcinoma was defined as number of days from the 1st day of study drug dosing for the participant to date of hepatocellular carcinoma. All hepatocellular carcinoma was to be included, whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for hepatocellular carcinoma. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
255 64455254 NCT02167945 primary All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event At Post-Treatment Weeks 52, 104, 156, 208, and 260 Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-I; NCT02219490.
256 65747703 NCT02171429 primary Percentage of Participants in Remission at Week 10 With Etrolizumab Compared With Placebo, as Determined by the Mayo Clinic Score (MCS), GA28949 Population Week 10 The Mayo Clinic Score (MCS) ranges from 0 to 12 and is a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease. Remission was defined as MCS less than or equal to (≤)2 with individual subscores ≤1 and a rectal bleeding subscore of 0. Participants were also classified as non-remitters if Week 10 assessments were missing or if they had received permitted/prohibited rescue therapy prior to assessment. Participants were stratified by concomitant treatment with corticosteroids or immunosuppressants at randomization and disease activity measured during screening (MCS ≤9/MCS ≥10); the Cochran-Mantel-Haenszel test adjusted the difference in remission rates and associated 95% confidence interval for the stratification factors.
257 65747271 NCT02175771 primary Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period Day 1 to Week 26 of the Treatment Period An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
258 65747136 NCT02177266 primary Number of Patients With Post Cardiac Surgery Atrial Fibrillation or Post-pericardiotomy Syndrome. Baseline to 3 months
259 65746687 NCT02185014 primary Percentage of Participants With Endoscopic Improvement at Week 40 in Participants With Endoscopic Improvement at Week 0 Week 40 Endoscopic improvement defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of ≤4 and at least a 2-point reduction compared with Study M14-115 (NCT02185014) Baseline and no subscore greater than 1 in any individual endoscopic variable. The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The Total Score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Nonresponder imputation (NRI) was used for missing data.
260 65746600 NCT02186873 primary Percentage of Participants Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16 Week 16 ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (>=)20% improvement from baseline in at least 3 of the 4 domains: patient's global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI [0=no functional impairment to 10= maximal impairment]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale [VAS]), and an absence of deterioration (defined as >=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain.
261 65746515 NCT02187159 primary Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo Baseline up to Week 13 postdose The patient reported pain intensity daily (over the past 24 hours) on a scale of 0 = no pain to 10 = worst possible pain. The daily pain scores were averaged over 7 days to calculate the weekly ADPS.
262 65745390 NCT02203032 primary Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40 Week 28 through Week 40 The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
263 65745174 NCT02207231 primary Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16 Week 16 The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
264 65745175 NCT02207231 primary Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16 Week 16 The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
265 65745154 NCT02207244 primary Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16 Week 16 The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
266 65745155 NCT02207244 primary Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16 Week 16 The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
267 65744359 NCT02218372 primary Percentage of Participants With Confirmed Clinical Response (CCR) at End of Treatment (EOT) +2 Days Up to day 12 Initial clinical response (ICR) for ages from birth to < 2 years was defined as absence of watery diarrhea for 2 consecutive treatment days, remaining well until study drug discontinuation. ICR for ages ≥ 2 years to < 18 years was defined as improvement in number and character of bowel movements as determined by < 3 unformed bowel movements (UBMs) per day for 2 consecutive treatment days, remaining well until study drug discontinuation. CCR was defined for both age groups as not requiring further CDAD therapy within 2 days after study drug completion, and was reported with a positive (Yes) or negative (No) outcome. Resolution of diarrhea was assessed during interviews of participant/parent/legal guardian, supplemented by review of personal records (if hospitalized) and checked for presence of watery diarrhea (ages from birth to < 2 years) or number of UBMs (for ages ≥ 2 years to < 18 years).
268 65742195 NCT02247804 primary Change From Baseline in IOP in the Study Eye at Week 12 (Hours 0 and 2) Baseline (Hours 0 and 2) to Week 12 (Hours 0 and 2) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
269 65742196 NCT02247804 primary IOP in the Study Eye at Week 2 (Hour 0) Week 2 (Hour 0) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
270 65742197 NCT02247804 primary IOP in the Study Eye at Week 2 (Hour 2) Week 2 (Hour 2) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
271 65742198 NCT02247804 primary IOP in the Study Eye at Week 6 (Hour 0) Week 6 (Hour 0) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
272 65742199 NCT02247804 primary IOP in the Study Eye at Week 6 (Hour 2) Week 6 (Hour 2) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
273 65742200 NCT02247804 primary IOP in the Study Eye at Week 12 (Hour 0) Week 12 (Hour 0) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
274 65742201 NCT02247804 primary IOP in the Study Eye at Week 12 (Hour 2) Week 12 (Hour 2) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
275 65742039 NCT02250651 primary Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
276 65742040 NCT02250651 primary IOP in the Study Eye at Week 2 (Hour 0) Week 2 (Hour 0) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
277 65742041 NCT02250651 primary IOP in the Study Eye at Week 2 (Hour 2) Week 2 (Hour 2) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
278 65742042 NCT02250651 primary IOP in the Study Eye at Week 6 (Hour 0) Week 6 (Hour 0) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
279 65742043 NCT02250651 primary IOP in the Study Eye at Week 6 (Hour 2) Week 6 (Hour 2) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
280 65742044 NCT02250651 primary IOP in the Study Eye at Week 12 (Hour 0) Week 12 (Hour 0) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
281 65742045 NCT02250651 primary IOP in the Study Eye at Week 12 (Hour 2) Week 12 (Hour 2) IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.
282 65742038 NCT02251275 primary Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment(+ 7 days) An adverse event (AE) was as any untoward medical occurrence associated with the use of an investigational medicinal product (IMP), whether or not considered IMP related. A TEAE was an AE that started after trial drug treatment; or if the event was continuous from baseline and was serious, related to IMP, or resulted in death, discontinuation, interruption or reduction of trial therapy. A serious TEAE included any event that resulted in: death, life-threatening, persistent or significant incapacity, substantial disruption of ability to conduct normal life functions, required inpatient hospitalization, prolonged hospitalization, congenital anomaly/birth defect, or other medically significant events as per medical judgment, that jeopardized the participant and that required medical or surgical intervention. A severe TEAE was an inability to work or perform normal daily activity. A summary of serious and all other non-serious TEAEs, regardless of causality, is located in the AE section.
283 65742022 NCT02251990 primary Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12) 12 weeks after end of all therapy (Study Week 24) Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® AmpliPrep/COBAS® Taqman HCV Test, v2.0, which had a lower limit of quantification (LLOQ) of 15 IU/mL. SVR12 was defined as HCV RNA below the lower limit of detection (<LLOQ) at 12 weeks after the end of all study therapy. As pre-specified in the protocol, the Deferred Treatment Group was not included in the primary efficacy analysis.
284 65742023 NCT02251990 primary Percentage of Participants Experiencing at Least One Adverse Event (AE) During the DB Treatment Period and First 14 Follow-up Days DB Treatment period plus first 14 follow-up days (up to 14 weeks) An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. The primary safety analysis compared the safety data of the Immediate Treatment Group during the active treatment period to those of the Deferred Treatment Group during the placebo treatment period.
285 65742024 NCT02251990 primary Percentage of Participants That Discontinued From Study Therapy Due to AEs During the DB Treatment Period DB Treatment period (up to 12 weeks) An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of the Sponsor's product, is also an AE. A participant could discontinue from treatment but continue to participate in the study as long as consent was not withdrawn. The primary safety analysis compared the safety data of the Immediate Treatment Group during the active treatment period to those of the Deferred Treatment Group during the placebo treatment period.
286 65741679 NCT02256436 primary Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) - All Participants Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was assessed by blinded independent central review (BICR) in all participants up through the primary analysis database cut-off date of 07-Sep-2016.
287 65741680 NCT02256436 primary Overall Survival (OS) - All Participants Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) OS was defined as the time from randomization to death due to any cause. The OS was assessed in all participants up through the primary analysis database cut-off date of 07-Sep-2016.
288 65741681 NCT02256436 primary PFS Per RECIST 1.1 - Participants With Programmed Cell Death-Ligand (PD-L1) Positive Tumors Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by BICR in all participants who had PD-L1 positive tumors (combined positive score [CPS] ≥1%) up through the primary analysis database cut-off date of 07-Sep-2016.
289 65741682 NCT02256436 primary OS - Participants With PD-L1 Positive Tumors Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) OS was defined as the time from randomization to death due to any cause. For the purposes of this study, participants with PD-L1 CPS ≥1% were considered to have a PD-L1 positive tumor status. OS was assessed in all participants who had PD-L1 positive tumors (CPS ≥1%) up through the primary analysis database cut-off date of 07-Sep-2016.
290 65741683 NCT02256436 primary PFS Per RECIST 1.1 - Participants With Strongly PD-L1 Positive Tumors Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 was assessed by BICR in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) up through the primary analysis database cut-off date of 07-Sep-2016.
291 65741684 NCT02256436 primary OS - Participants With Strongly PD-L1 Positive Tumors Through primary analysis database cut-off date of 07-Sep-2016 (Up to approximately 20 months) OS was defined as the time from randomization to death due to any cause. For the purposes of this study, participants with a PD-L1 CPS ≥10% were considered to have a strongly PD-L1 positive tumor status. The OS was assessed in all participants who had strongly PD-L1 positive tumors (CPS ≥10%) up through the primary analysis database cut-off date of 07-Sep-2016.
292 65741169 NCT02263079 primary Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) at 24 Weeks Post-End of Treatment/End of Untreated Observation 24 weeks post-treatment/at the end of untreated observation (Week 80) This endpoint is defined as loss of HBsAg at 24 weeks post-treatment (follow-up Week 24)/end of untreated observation (Week 80). The percentage of responders (response rate) and 95% CI (using the Clopper-Pearson method) for the response rate are presented for each group.
293 65741132 NCT02263508 primary Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) The DLT evaluation period was 6 weeks from the initial administration of pembrolizumab (week 6 to 12). A DLT was defined as any toxicity related to study drug which met any of the following criteria based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0: Grade 4 non-hematologic toxicity. Grade 3 or higher pneumonitis. Grade 3 non-hematologic toxicity lasting > 3 days despite optimal supportive care, excluding grade 3 fatigue. Any grade 3 or higher non-hematologic laboratory value if medical intervention was required, or the abnormality lead to hospitalization, or the abnormality persisted for > 1 week. Febrile neutropenia grade 3 or grade 4. Thrombocytopenia < 25 x 10^9/L if associated with a bleeding event which does not result in hemodynamic instability but required an elective platelet infusion, or a life-threatening bleeding event which resulted in urgent intervention and admission to intensive care unit. Grade 5 toxicity (ie, death). Any other intolerable toxicity leading to permanent discontinuation of talimogene laherparepvec or pembrolizumab.
294 65741133 NCT02263508 primary Phase 3: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessed Using Modified RECIST 1.1 From randomization until the data-cut-off date of 02 March 2020; median (range) time on follow-up was 25.5 (0.6, 44.7) months in the Placebo + Pembrolizumab arm and 25.6 (0.3, 45.8) months in the Talimogene Laherparepvec + Pembrolizumab arm. PFS per modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 is defined as the interval from randomization to the earlier event of progressive disease (PD) per modified RECIST 1.1 or death from any cause. PD: Increase in size of target lesions from nadir by ≥ 20% and ≥ 5 mm absolute increase above nadir, or the appearance of a new lesion. Median PFS was calculated using the Kaplan-Meier method. Participants without an event were censored at their last evaluable tumor assessment if available; otherwise on their randomization date. The primary analysis of PFS was specified to be conducted when 407 PFS events had occurred (data cut-off date 02 March 2020).
295 65741134 NCT02263508 primary Phase 3: Overall Survival From randomization until the end of study; median (range) time on follow-up was 34.8 (0.6, 58.3) months in the Placebo + Pembrolizumab arm and 36.8 (0.3, 58.4) months in the Talimogene Laherparepvec + Pembrolizumab arm. Overall survival (OS) is defined as the interval from randomization to death from any cause. Median overall survival was calculated using the Kaplan-Meier method. Participants without an event were censored at their last known alive date.
296 65741096 NCT02264990 primary Overall Survival (OS) in the Lung Subtype Panel Positive Subgroup From randomization up to the data cut-off date of 15 July 2019; median follow-up time was 44.5 and 45.3 months in LSP+ participants for the investigator's choice chemotherapy and veliparib + C/P arms, respectively. Overall survival is defined as the time from the date that the participant was randomized to the date of the participant's death. Overall survival was estimated using Kaplan-Meier methodology. Participants still alive at the data cut-off date were censored at the date they were last known to be alive.
297 65741091 NCT02265237 primary Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) 12 weeks after the last actual dose of study drug SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug.
298 65740594 NCT02272725 primary Acute Kidney Injury participants will be followed through the duration of a 50 mile ultramarathon, an expected average of 18 hours The participants experiencing acute kidney injury (diagnosed by an increase in creatinine of greater or equal to 1.5x that of estimated baseline creatinine from age and weight) will be from measured point-of-care blood test of the finish line immediately following the completion of a 50 mile ultramarathon. This outcome measure is a biochemical reading, that may not necessarily be a clinical adverse event.
299 65739123 NCT02291549 primary Nasal Obstruction/Congestion Score Day 30 Determined by patients using a daily diary on a scale from 0 (no symptoms) to 3 (severe symptoms) over a period of 7 days prior to the baseline and Day 30 visits. Negative values for change from baseline indicate reduction (improvement) in nasal obstruction/congestion symptoms.
300 65739124 NCT02291549 primary Bilateral Polyp Grade Day 90 Polyp grade was determined by an independent panel of 3 sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline indicated reduction (improvement) in bilateral polyp grade.
301 65738920 NCT02293902 primary Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 Week 24 American College of Rheumatology (ACR) response is a composite rating scale that includes 7 variables: tender joints count (TJC [68 joints]); Swollen joints count (SJC [66 joints]); levels of an acute phase reactant (high sensitivity C-reactive protein [hs-CRP level]); participant's assessment of pain (measured on 0 [no pain]-100 mm [worst pain] visual analog scale [VAS]); participant's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); physician's global assessment of disease activity (measured on 0 [no arthritis activity]-100 mm [maximal arthritis activity] VAS); participant's assessment of physical function (measured by health assessment questionnaire disability index [HAQ-DI], with scoring range of 0 [better health] - 3 [worst health]). ACR20 response was defined as achieving at least 20% improvement in both TJC and SJC, and at least 20% improvement in at least 3 of the 5 other assessments.
302 65738066 NCT02305849 primary Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12 Baseline and week 12/Early termination (ET) ACR20 response: greater than and equal to (≥) 20 percent (%) improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
303 65738067 NCT02305849 primary Change From Baseline in mTSS at Week 28 Baseline and week 28/ET mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 28 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
304 65737977 NCT02307682 primary Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye Baseline, Week 48 BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
305 65737876 NCT02308163 primary Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12 Baseline and Week 12/early termination (ET) The ACR20 response required that all criteria from (1) to (3) below be met. Tender joint count (TJC) : ≥ 20% reduction compared with baseline. Swollen joint count (SJC) : ≥ 20% reduction compared with baseline. ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline (3) ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, Subject's Global Assessment of Arthritis (SGA), Physician's Global Assessment of Arthritis (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), C-Reactive Protein (CRP).
306 65737433 NCT02313909 primary Incidence Rate of the Composite Efficacy Outcome (Adjudicated) From randomization until the efficacy cut-off date (median 326 days) Components of composite efficacy outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) and systemic embolism. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
307 65737434 NCT02313909 primary Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated) From randomization until the efficacy cut-off date (median 326 days) Major bleeding event (as per ISTH), defined as bleeding event that met at least one of following: fatal bleeding; symptomatic bleeding in a critical area or organ (intraarticular, intramuscular with compartment syndrome, intraocular, intraspinal, pericardial, or retroperitoneal); symptomatic intracranial haemorrhage; clinically overt bleeding associated with a recent decrease in the hemoglobin level of greater than or equal to (>=) 2 grams per decilitre (g/dL) (20 grams per liter [g/L]; 1.24 millimoles per liter [mmol/L]) compared to the most recent hemoglobin value available before the event; clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. The results were based on classification of events that have been positively adjudicated as major bleeding events. Incidence rate estimated as number of subjects with incident events divided by cumulative at-risk time, where subject is no longer at risk once an incident event occurred.
308 65737407 NCT02314117 primary Progression-free Survival (PFS) Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 Months) PFS time was measured from the date of randomization to the date of radiographic(rgr) documentation of progression(by RECIST v.1.1) or the date of death due to any cause, whichever was earlier.If a participant did not have a complete baseline tumor assessment,then the PFS time was censored at the randomization date.If a participant was not known to have died or have rgr documented progression as of the data cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. If death or progressive disease(PD) occurred after 2 or more consecutive missing rgr visits,censoring occurred at the date of the last rgr visit prior to the missed visits.If death or PD occurred after postdiscontinuation(pdis) systemic anticancer therapy,censoring occurred at the date of last rgr visit prior to the start of pdis systemic anticancer therapy. PD was defined according to RECIST v.1.1.
309 66131033 NCT02325466 primary Mean Change in Low Shear Blood Viscosity baseline, week 16 Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity from week 16 to baseline
310 66131034 NCT02325466 primary Mean Change in High Shear Blood Viscosity baseline and week 16 Compare the effect of aspirin-ticagrelor and ticagrelor monotherapy with aspirin on blood viscosity at week 16 to baseline
311 65736459 NCT02326272 primary Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16 Week 16 The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
312 65736460 NCT02326272 primary Proportion of Participants Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16 Week 16 The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
313 65736453 NCT02326298 primary Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16 At Week 16 The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
314 65736454 NCT02326298 primary Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear (With at Least 2-category Improvement) Response at Week 16 At Week 16 The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
315 65735593 NCT02340221 primary Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) at Primary Analysis From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
316 65735594 NCT02340221 primary PFS as Assessed by Investigator Using RECIST v1.1 at Final Analysis From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to approximately 6.2 years) PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
317 65735264 NCT02343458 primary Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach) at week 24 For the US/China approach, the primary endpoint was the change from baseline in morning pre-dose trough FEV1 at Week 24 of treatment
318 65735265 NCT02343458 primary Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach over weeks 12-24 Change from baseline in morning pre-dose trough FEV1 over weeks 12-24, Japan approach
319 65735266 NCT02343458 primary Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach. over 24 weeks Change from baseline in morning pre-dose trough FEV1 over 24 weeks. Primary endpoint, EU/SK/TW approach, Secondary endpoint US/China approach.
320 65735069 NCT02346240 primary Proportion of Subjects Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 Week 12 The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
321 65735047 NCT02346721 primary Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) Posttreatment Week 12 SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
322 65735048 NCT02346721 primary Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event Up to 12 weeks
323 65733078 NCT02370498 primary Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants Up to 30 months (through database cut-off date of 26 Oct 2017) PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval [CI]) in months was reported for PD-L1 positive participants by treatment group.
324 65733079 NCT02370498 primary Overall Survival (OS) in PD-L1 Positive Participants Up to 30 months (through database cut-off date of 26 Oct 2017) OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and median OS (95% CI) in months was reported for PD-L1 positive participants by treatment group.
325 65732884 NCT02373202 primary Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Baseline up to Week 58 Adverse event (AE) was defined as any untoward medical occurrence in a participant who received IMP and did not necessary have to had a causal relationship with treatment. All AEs that occurred from the first dose of the IMP administration up to 6 weeks after last dose of treatment (up to Week 58) were considered as TEAEs. SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death initial or prolonged inpatient hospitalization life-threatening experience (immediate risk of dying) persistent or significant disability/incapacity congenital anomaly or a medically important event. TEAEs included both SAEs and non-SAEs.
326 65732885 NCT02373202 primary Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities Baseline up to Week 58 Criteria for potentially clinically significant vital sign abnormalities: Systolic blood pressure (SBP) supine: <=95 mmHg and decrease from baseline (DFB) >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg Diastolic blood pressure (DBP) supine: <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB ≥10 mmHg SBP (Orthostatic): <=-20 mmHg DBP (Orthostatic): <=-10 mmHg Heart rate (HR) supine: <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm Weight: >=5% DFB; >=5% IFB
327 65732886 NCT02373202 primary Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities Baseline up to Week 58 Criteria for potentially clinically significant ECG abnormalities: PR Interval: >200 milliseconds (ms); >200 ms and IFB >=25%; >220 ms; >220 ms and IFB >=25%; >240 ms; >240 ms and IFB >=25% QRS Interval: >110 ms; >110 ms and IFB >=25%; >120 ms; >120 ms and IFB >=25% QT Interval: >500 ms QTc Bazett (QTc B): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms, IFB >60 ms QTc Fridericia (QTc F): >450 ms; >480 ms; >500 ms; IFB >30 and <=60 ms; IFB >60 ms
328 65732887 NCT02373202 primary Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters Baseline up to Week 58 Criteria for potentially clinically significant abnormalities: Hemoglobin: <=115 g/L (Male[M]) or <=95 g/L (Female[F]); >=185 g/L (M) or >=165 g/L (F); DFB >=20 g/L Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F); >=0.55 v/v (M) or >=0.5 v/v (F) Red blood cells (RBC): >=6 Tera/L Platelets: <50 Giga/L; >=50 and <100 Giga/L; >=700 Giga/L White blood cells (WBC): <3.0 Giga/L (Non-Black [NB]) or <2.0 Giga/L (Black [B]); >=16.0 Giga/L Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); <1.0 Giga/L Lymphocytes: <0.5 Giga/L; >=0.5 Giga/L and <lower limit of normal (LLN); >4.0 Giga/L Monocytes: >0.7 Giga/L Basophils: >0.1 Giga/L Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L)
329 65732888 NCT02373202 primary Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters Baseline up to Week 58 Criteria for potentially clinically significant abnormalities: Glucose: <=3.9 mmol/L and <LLN; >=11.1 mmol/L (unfasted [unfas]) or >=7 mmol/L (fasted [fas]) Hemoglobin A1c (HbA1c): >8% Total cholesterol: >=6.2 mmol/L; >=7.74 mmol/L LDL cholesterol: >=4.1 mmol/L; >=4.9 mmol/L Triglycerides: >=4.6 mmol/L; >=5.6 mmol/L
330 65732889 NCT02373202 primary Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes Baseline up to Week 58 Criteria for potentially clinically significant abnormalities: Sodium: <=129 mmol/L; >=160 mmol/L Potassium: <3 mmol/L; >=5.5 mmol/L Chloride: <80 mmol/L; >115 mmol/L
331 65732890 NCT02373202 primary Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters Baseline up to Week 58 Criteria for potentially clinically significant abnormalities: Creatinine: >=150 micromol/L (adults); >=30% change from baseline, >=100% change from baseline Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to <60 mL/min; >=60 to <90 mL/min Blood urea nitrogen: >=17 mmol/L Uric acid: <120 micromol/L; >408 micromol/L
332 65732891 NCT02373202 primary Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters Baseline up to Week 58 Criteria for potentially clinically significant abnormalities: Alanine Aminotransferase (ALT): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN Aspartate aminotransferase (AST): >1 ULN and <=1.5 ULN; >1.5 ULN and <=3 ULN; >3 ULN and <=5 ULN; >5 ULN and <=10 ULN; >10 ULN and <=20 ULN; >20 ULN Alkaline phosphatase: >1.5 ULN Total bilirubin (TBILI): >1.5 ULN; >2 ULN Conjugated bilirubin(CBILI): >1.5 ULN Unconjugated bilirubin: >1.5 ULN ALT >3 ULN and TBILI >2 ULN CBILI >35% TBILI and TBILI >1.5 ULN Albumin: <=25 g/L
333 65732795 NCT02375971 primary Percentage of Participants With Absence of Active ROP and Absence of Unfavorable Structural Outcomes in Both Eyes at Week 24 Week 24 To achieve this outcome, patients must fulfill all the following criteria, 1) survival, 2) no intervention with a second modality for ROP, 3) absence of active ROP and 4) absence of unfavorable structural outcome. Retinopathy of prematurity (ROP) is a pathologic process that occurs in the incompletely vascularized, developing retina of low birth-weight preterm neonates.
334 66130931 NCT02381652 primary Number of Treatment-Emergent Adverse Events: Cingal 13-02 vs. Cingal 13-01 Baseline through 6 weeks post-injection The primary outcome measure will compare safety results (all adverse events, whether related to the study injection or not) for Cingal 13-01 and Cingal 13-02.
335 65731360 NCT02396316 primary Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1 From baseline to pre-dose at Week 1 It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group.
336 65730311 NCT02410772 primary TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Modified Intent to Treat [MITT] Population) Twelve months after treatment assignment To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis A primary outcome status of "favorable", "unfavorable", or "not assessable" was assigned. For detailed definitions of outcomes please refer to: Dorman SE, at al. N Engl J Med. 2021 May 6;384(18):1705-1718.
337 65730312 NCT02410772 primary TB Disease-free Survival at 12M After Study Treatment Assignment Among Participants in Control Regimen, Regimen1 (2HRZE/4HR) to Experimental Regimens, Regimen3 (2HPZM/2HPM) and Regimen2 (2HPZ/2HP) (Assessable Population) Twelve months after treatment assignment To evaluate the efficacy of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis To evaluate the efficacy of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis A primary outcome status of "favorable", "unfavorable", or "not assessable" was assigned. For detailed definitions of outcomes please refer to: Dorman SE, at al. N Engl J Med. 2021 May 6;384(18):1705-1718.
338 65730313 NCT02410772 primary Percentage Participants With Grade 3 or Higher Adverse Events During Study Drug Treatment in Control Regimen (Regimen 1 2HRZE/4HR) Compared to Experimental Regimens, Regimen 3 (2HPZM/2HPM) and Regimen 2 (2HPZ/2HP) (Safety Analysis Population) Four months and up to 14 days after last does of after study treatment (Regimen 2 and 3) or Six months and up to 14 days after last does of after study treatment (Regimen 1) To evaluate the Safety of a rifapentine-containing regimen to determine whether the single substitution of rifapentine for rifampin makes it possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis To evaluate the Safety of a rifapentine-containing regimen that in addition substitutes moxifloxacin for ethambutol and continues moxifloxacin during the continuation phase, to determine whether it is possible to reduce to seventeen weeks the duration of treatment for drug-susceptible pulmonary tuberculosis Grade 3 or higher Adverse Events are collected by Clinical sites in systematic way through the laboratory tests and physical exam during regular study follow up visits and also in a non-systematic way when it was self-reported by participants during the study visits. The events are graded by site investigators per Common Terminology Criteria for Adverse Events (CTCAE V4.03
339 64226215 NCT02425644 primary Annualized Confirmed Relapse Rate From randomization to end of study (Week 108) Relapse: occurrence of acute episode of one or more new symptoms or worsened symptoms of Multiple sclerosis (MS), not associated with fever/infection and lasting 24 hours after stable 30 days period. Confirmed relapse: increase from baseline at least 0.5 point Expanded Disability Status Scale (EDSS) score or increase of one point in one, two or three Functional Systems (FS), excluding bowel/bladder and cerebral/mental FS. EDSS and FS scores are based on neurological examination for assessing its impairment in MS. Among eight FS, seven are ordinal clinical rating scales ranging from 0-5 or 6 with higher scale indicates overall functional impairment assessing Visual,Brain Stem,Pyramidal,Cerebellar,Sensory, Bowel/Bladder and Cerebral functions. Rating individual FS scores is used to rate EDSS in conjunction with observations and information concerning gait and use of assistance. EDSS is ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10(death due to MS).
340 65728673 NCT02434328 primary Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye Baseline, Week 48 BCVA (with spectacles or other visual corrective devices) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing at 4 meters and reported in letters read correctly. Baseline was defined as the last measurement prior to first treatment. An increase (gain) in letters read from the baseline assessment indicates improvement. One eye (study eye) contributed to the analysis.
341 65728403 NCT02437162 primary Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 24 Week 24 ASAS 40 defined as improvement from baseline of greater than or equal to (>=) 40 percent (%) and absolute improvement from baseline of at least 2 on 0 to 10 centimeter (cm) scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation(0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
342 65726374 NCT02462486 primary Percentage of Participants With Stable Vision at Week 52 Baseline to Week 52 Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-dominant eye, or else right eye was selected as study eye.
343 65726321 NCT02462928 primary Percentage of Participants With Stable Vision at Week 52 Baseline to Week 52 Stable vision was defined as a loss of fewer than 15 letters in BCVA compared to baseline. BCVA was measured using an eye chart and reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or else the right eye was selected as the study eye.
344 65725831 NCT02472886 primary Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) Posttreatment Week 12 SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
345 65725832 NCT02472886 primary Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE) Up to 12 weeks
346 65719724 NCT02540954 primary Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye From baseline to Week 52 Visual function was assessed with the procedure from the ETDRS adapted for the Age Related Eye Disease Study using charts with 70 letters at a starting distance of 4 meters. Charts are organized in 14 lines of decreasing size with 5 letters each. Participants reading up to 19 letters at 4 meters were tested at 1 meter to read the first 6 lines. The score equals the sum of letters read at 1 meter and 4 meters. If more than 19 letters are read at 4 meters the score equals the number of letters read plus 30. The score range is 0 to 100, and a higher score represents better visual function.

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### Template:
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* Plan/Todo [2025-01-06]
Goal is to update the main images with more details, i.e. adding means
etc.
- get aact_db back up
- attach it to a "research" network
- restart rocker, attaching it to the same research network.
** NOTES
aact_db-restored-2024-11-27 didn't successfully restore. It is missing
all the important stuff.
Figured out why the restore was failing. My code to restore had a faulty
check to see if the DB was up and ready. Fixed that now.
Waiting for restore (manually triggered) to start. Then I should have
access to the table as needed.
It seems like I'm missing some data within a schema, specifically the
Formularies and their associated views.
My options are:
- search around for documentation or other stuff
- try to rebuild
my suspision is that I forgot to back it up. I think it is probably
worth looking for. - So I've been looking through my copy of
ClinicalTrialsDataProcessing, and have not found anything referencing
it. The formularies data is required for my analysis though. If I
remember correctly, I manually uploaded the USP datasets in DBeaver,
then created any views etc.
I think that I'll have to recreate it. This is going to be hard because
I'm not sure what it did. At least I created mildly informative table
names.
The tables/views I've identified are: -
=Formularies.nct_to_brands_through_uspdc=
It looks like I need to - import usp-dc dataset - link those drugs to
usp data - create a view that links those automatically - back it up. -
double check the data I get from the request.
The links will be through RXCUIs, and grouped on =USP Class= In effect,
for a given RXCUI, I want to get the list of RXCUI's which have the same
USP-DC class, and then be able to link back to brands.
This should have the following links: - RXCUI -> USP-DC category/class
pair - USP-DC category/class pair -> RXCUIs - RXUCIs -> competitors
Do I want to combine the USP-DC and UPS-MMG datasets? No, there is
enough difference in them that I don't want to have to handle it that
way.
I've been working on this in scripts/ConfiguringFormularies.sql
So what I've managed to do so far is export tables, backup the data.
I've got a version that connects trials to brand names, but there may be
more details to the connection than I thought. I'd like to check if I
need to filter anything or check if there are other ingredients etc that
I need to include. */I probably need to write some descriptions of all
the tables and views to put everything together. An ai would probably be
helpful in doing this./*
** Code snippets
#+begin_example
podman run \
-e POSTGRES_PASSWORD="${POSTGRES_PASSWORD}" \
-e POSTGRES_USER="${POSTGRES_USER}" \
-e POSTGRES_DB="${POSTGRES_DB}" \
--name "${CONTAINER_NAME}" \
--detach \
--network research-network \
--shm-size=512mb \
--volume ./backup/:/backup/ \
-p 5432:5432\
postgres:14-alpine
#+end_example
#+begin_example
function check_postgres {
podman exec -i "${POSTGRES_DB}" psql -h localhost -U "${POSTGRES_USER}" -d "${POSTGRES_DB}" -c '\q' > /dev/null 2>&1
}
#+end_example
** Notes at end of day
- was reasonably productive in getting stuff unblocked for finishing
JMP, which i'll need to do before I leave town next week.
** What I've got to do tomorrow
I've got a version that connects trials to brand names, but there may be
more details to the connection than I thought. I'd like to check if I
need to filter anything or check if there are other ingredients etc that
I need to include. */I probably need to write some descriptions of all
the tables and views to put everything together. An ai would probably be
helpful in doing this./* At the end of it all, I should be able to get a
count of competing drugs per trial.
Once that is done, I can relink aact_db and rocker, then rerun my
analysis. Then I can adjust the images that I need for my JMP.
* [2025-01-07 Tue 12:01] notes
So what I've got to do is
** DONE Investigate what compounds are showing up in my current list
if that is what I want, then I'll be able proceed with redoing my images
if not, then I'll have to work on adjusting the views etc that I have.
I've looked through it and it seems to correct.
*** [[/mnt/will/large_data/Research_large_data/ClinicalTrialsDataProcessing/Scripts/ConfiguringFormularies.sql][ConfiguringFormularies.sql:81]] [2025-01-07 Tue 13:24]
I've tweaked these three views to make them clearer.
I also renamed the view of interest to ="Formularies".nct_to_brand_counts_through_uspdc= to better represent what it does.
** DONE Rerun the analysis
CLOSED: [2025-01-07 Tue 16:39]
So it looks like I'll need to
1. take a backup of aact_db
2. restore from backup, putting the container in the research network
3. then rerun the analysis.
Ok, I'm pushing the backup and can get started on restoring from backup.
Backup is restoring. As I recall, this takes 40 minutes.
had some mild tweaks to match the new results
it now runs
** DONE Add more details to images
CLOSED: [2025-01-13 Mon 10:26]
The details I want to add include:
- [x] sample sizes for breakdowns
- [x] box and whisker plot along the bottom of the large values
[[https://claude.ai/chat/0e6b6368-130e-4aa8-aa16-97b6c937bba4]] has details

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Cause ID,Cause Name,Parent ID,Parent Name,Level,Cause Outline,Sort Order,YLL Only,YLD Only
294,All causes,294,All causes,0,Total,1,,
295,"Communicable, maternal, neonatal, and nutritional diseases",294,All causes,1,A,2,,
955,HIV/AIDS and sexually transmitted infections,295,"Communicable, maternal, neonatal, and nutritional diseases",2,A.1,3,,
298,HIV/AIDS,955,HIV/AIDS and sexually transmitted infections,3,A.1.1,4,,
948,HIV/AIDS - Drug-susceptible Tuberculosis,298,HIV/AIDS,4,A.1.1.1,5,,
949,HIV/AIDS - Multidrug-resistant Tuberculosis without extensive drug resistance,298,HIV/AIDS,4,A.1.1.2,6,,
950,HIV/AIDS - Extensively drug-resistant Tuberculosis,298,HIV/AIDS,4,A.1.1.3,7,,
300,HIV/AIDS resulting in other diseases,298,HIV/AIDS,4,A.1.1.4,8,,
393,Sexually transmitted infections excluding HIV,955,HIV/AIDS and sexually transmitted infections,3,A.1.2,9,,
394,Syphilis,393,Sexually transmitted infections excluding HIV,4,A.1.2.1,10,,
395,Chlamydial infection,393,Sexually transmitted infections excluding HIV,4,A.1.2.2,11,,
396,Gonococcal infection,393,Sexually transmitted infections excluding HIV,4,A.1.2.3,12,,
397,Trichomoniasis,393,Sexually transmitted infections excluding HIV,4,A.1.2.4,13,,X
398,Genital herpes,393,Sexually transmitted infections excluding HIV,4,A.1.2.5,14,,X
399,Other sexually transmitted infections,393,Sexually transmitted infections excluding HIV,4,A.1.2.6,15,,
956,Respiratory infections and tuberculosis,295,"Communicable, maternal, neonatal, and nutritional diseases",2,A.2,16,,
297,Tuberculosis,956,Respiratory infections and tuberculosis,3,A.2.1,17,,
954,Latent tuberculosis infection,297,Tuberculosis,4,A.2.1.1,18,,X
934,Drug-susceptible tuberculosis,297,Tuberculosis,4,A.2.1.2,19,,
946,Multidrug-resistant tuberculosis without extensive drug resistance,297,Tuberculosis,4,A.2.1.3,20,,
947,Extensively drug-resistant tuberculosis,297,Tuberculosis,4,A.2.1.4,21,,
322,Lower respiratory infections,956,Respiratory infections and tuberculosis,3,A.2.2,22,,
328,Upper respiratory infections,956,Respiratory infections and tuberculosis,3,A.2.3,23,,
329,Otitis media,956,Respiratory infections and tuberculosis,3,A.2.4,24,,
957,Enteric infections,295,"Communicable, maternal, neonatal, and nutritional diseases",2,A.3,25,,
302,Diarrheal diseases,957,Enteric infections,3,A.3.1,26,,
958,Typhoid and paratyphoid,957,Enteric infections,3,A.3.2,27,,
319,Typhoid fever,958,Typhoid and paratyphoid,4,A.3.2.1,28,,
320,Paratyphoid fever,958,Typhoid and paratyphoid,4,A.3.2.2,29,,
959,Invasive Non-typhoidal Salmonella (iNTS),957,Enteric infections,3,A.3.3,30,,
321,Other intestinal infectious diseases,957,Enteric infections,3,A.3.4,31,,
344,Neglected tropical diseases and malaria,295,"Communicable, maternal, neonatal, and nutritional diseases",2,A.4,32,,
345,Malaria,344,Neglected tropical diseases and malaria,3,A.4.1,33,,
346,Chagas disease,344,Neglected tropical diseases and malaria,3,A.4.2,34,,
347,Leishmaniasis,344,Neglected tropical diseases and malaria,3,A.4.3,35,,
348,Visceral leishmaniasis,347,Leishmaniasis,4,A.4.3.1,36,,
349,Cutaneous and mucocutaneous leishmaniasis,347,Leishmaniasis,4,A.4.3.2,37,,X
350,African trypanosomiasis,344,Neglected tropical diseases and malaria,3,A.4.4,38,,
351,Schistosomiasis,344,Neglected tropical diseases and malaria,3,A.4.5,39,,
352,Cysticercosis,344,Neglected tropical diseases and malaria,3,A.4.6,40,,
353,Cystic echinococcosis,344,Neglected tropical diseases and malaria,3,A.4.7,41,,
354,Lymphatic filariasis,344,Neglected tropical diseases and malaria,3,A.4.8,42,,X
355,Onchocerciasis,344,Neglected tropical diseases and malaria,3,A.4.9,43,,X
356,Trachoma,344,Neglected tropical diseases and malaria,3,A.4.10,44,,X
357,Dengue,344,Neglected tropical diseases and malaria,3,A.4.11,45,,
358,Yellow fever,344,Neglected tropical diseases and malaria,3,A.4.12,46,,
359,Rabies,344,Neglected tropical diseases and malaria,3,A.4.13,47,,
360,Intestinal nematode infections,344,Neglected tropical diseases and malaria,3,A.4.14,48,,
361,Ascariasis,360,Intestinal nematode infections,4,A.4.14.1,49,,
362,Trichuriasis,360,Intestinal nematode infections,4,A.4.14.2,50,,X
363,Hookworm disease,360,Intestinal nematode infections,4,A.4.14.3,51,,X
364,Food-borne trematodiases,344,Neglected tropical diseases and malaria,3,A.4.15,52,,X
405,Leprosy,344,Neglected tropical diseases and malaria,3,A.4.16,53,,X
843,Ebola,344,Neglected tropical diseases and malaria,3,A.4.17,54,,
935,Zika virus,344,Neglected tropical diseases and malaria,3,A.4.18,55,,
936,Guinea worm disease,344,Neglected tropical diseases and malaria,3,A.4.19,56,,X
365,Other neglected tropical diseases,344,Neglected tropical diseases and malaria,3,A.4.20,57,,
961,Other infectious diseases,295,"Communicable, maternal, neonatal, and nutritional diseases",2,A.5,58,,
332,Meningitis,961,Other infectious diseases,3,A.5.1,59,,
337,Encephalitis,961,Other infectious diseases,3,A.5.2,60,,
338,Diphtheria,961,Other infectious diseases,3,A.5.3,61,,
339,Whooping cough,961,Other infectious diseases,3,A.5.4,62,,
340,Tetanus,961,Other infectious diseases,3,A.5.5,63,,
341,Measles,961,Other infectious diseases,3,A.5.6,64,,
342,Varicella and herpes zoster,961,Other infectious diseases,3,A.5.7,65,,
400,Acute hepatitis,961,Other infectious diseases,3,A.5.8,66,,
401,Acute hepatitis A,400,Acute hepatitis,4,A.5.8.1,67,,
402,Acute hepatitis B,400,Acute hepatitis,4,A.5.8.2,68,,
403,Acute hepatitis C,400,Acute hepatitis,4,A.5.8.3,69,,
404,Acute hepatitis E,400,Acute hepatitis,4,A.5.8.4,70,,
408,Other unspecified infectious diseases,961,Other infectious diseases,3,A.5.9,71,,
962,Maternal and neonatal disorders,295,"Communicable, maternal, neonatal, and nutritional diseases",2,A.6,72,,
366,Maternal disorders,962,Maternal and neonatal disorders,3,A.6.1,73,,
367,Maternal hemorrhage,366,Maternal disorders,4,A.6.1.1,74,,
368,Maternal sepsis and other maternal infections,366,Maternal disorders,4,A.6.1.2,75,,
369,Maternal hypertensive disorders,366,Maternal disorders,4,A.6.1.3,76,,
370,Maternal obstructed labor and uterine rupture,366,Maternal disorders,4,A.6.1.4,77,,
995,Maternal abortion and miscarriage,366,Maternal disorders,4,A.6.1.5,78,,
374,Ectopic pregnancy,366,Maternal disorders,4,A.6.1.6,79,,
375,Indirect maternal deaths,366,Maternal disorders,4,A.6.1.7,80,X,
376,Late maternal deaths,366,Maternal disorders,4,A.6.1.8,81,X,
741,Maternal deaths aggravated by HIV/AIDS,366,Maternal disorders,4,A.6.1.9,82,X,
379,Other maternal disorders,366,Maternal disorders,4,A.6.1.10,83,,
380,Neonatal disorders,962,Maternal and neonatal disorders,3,A.6.2,84,,
381,Neonatal preterm birth,380,Neonatal disorders,4,A.6.2.1,85,,
382,Neonatal encephalopathy due to birth asphyxia and trauma,380,Neonatal disorders,4,A.6.2.2,86,,
383,Neonatal sepsis and other neonatal infections,380,Neonatal disorders,4,A.6.2.3,87,,
384,Hemolytic disease and other neonatal jaundice,380,Neonatal disorders,4,A.6.2.4,88,,
385,Other neonatal disorders,380,Neonatal disorders,4,A.6.2.5,89,,
386,Nutritional deficiencies,295,"Communicable, maternal, neonatal, and nutritional diseases",2,A.7,90,,
387,Protein-energy malnutrition,386,Nutritional deficiencies,3,A.7.1,91,,
388,Iodine deficiency,386,Nutritional deficiencies,3,A.7.2,92,,X
389,Vitamin A deficiency,386,Nutritional deficiencies,3,A.7.3,93,,X
390,Dietary iron deficiency,386,Nutritional deficiencies,3,A.7.4,94,,X
391,Other nutritional deficiencies,386,Nutritional deficiencies,3,A.7.5,95,,
409,Non-communicable diseases,294,All causes,1,B,96,,
410,Neoplasms,409,Non-communicable diseases,2,B.1,97,,
444,Lip and oral cavity cancer,410,Neoplasms,3,B.1.1,98,,
447,Nasopharynx cancer,410,Neoplasms,3,B.1.2,99,,
450,Other pharynx cancer,410,Neoplasms,3,B.1.3,100,,
411,Esophageal cancer,410,Neoplasms,3,B.1.4,101,,
414,Stomach cancer,410,Neoplasms,3,B.1.5,102,,
441,Colon and rectum cancer,410,Neoplasms,3,B.1.6,103,,
417,Liver cancer,410,Neoplasms,3,B.1.7,104,,
418,Liver cancer due to hepatitis B,417,Liver cancer,4,B.1.7.1,105,,
419,Liver cancer due to hepatitis C,417,Liver cancer,4,B.1.7.2,106,,
420,Liver cancer due to alcohol use,417,Liver cancer,4,B.1.7.3,107,,
996,Liver cancer due to NASH,417,Liver cancer,4,B.1.7.4,108,,
1021,Liver cancer due to other causes,417,Liver cancer,4,B.1.7.5,109,,
453,Gallbladder and biliary tract cancer,410,Neoplasms,3,B.1.8,110,,
456,Pancreatic cancer,410,Neoplasms,3,B.1.9,111,,
423,Larynx cancer,410,Neoplasms,3,B.1.10,112,,
426,"Tracheal, bronchus, and lung cancer",410,Neoplasms,3,B.1.11,113,,
459,Malignant skin melanoma,410,Neoplasms,3,B.1.12,114,,
462,Non-melanoma skin cancer,410,Neoplasms,3,B.1.13,115,,
849,Non-melanoma skin cancer (squamous-cell carcinoma),462,Non-melanoma skin cancer,4,B.1.13.1,116,,
850,Non-melanoma skin cancer (basal-cell carcinoma),462,Non-melanoma skin cancer,4,B.1.13.2,117,,X
429,Breast cancer,410,Neoplasms,3,B.1.14,118,,
432,Cervical cancer,410,Neoplasms,3,B.1.15,119,,
435,Uterine cancer,410,Neoplasms,3,B.1.16,120,,
465,Ovarian cancer,410,Neoplasms,3,B.1.17,121,,
438,Prostate cancer,410,Neoplasms,3,B.1.18,122,,
468,Testicular cancer,410,Neoplasms,3,B.1.19,123,,
471,Kidney cancer,410,Neoplasms,3,B.1.20,124,,
474,Bladder cancer,410,Neoplasms,3,B.1.21,125,,
477,Brain and central nervous system cancer,410,Neoplasms,3,B.1.22,126,,
480,Thyroid cancer,410,Neoplasms,3,B.1.23,127,,
483,Mesothelioma,410,Neoplasms,3,B.1.24,128,,
484,Hodgkin lymphoma,410,Neoplasms,3,B.1.25,129,,
485,Non-Hodgkin lymphoma,410,Neoplasms,3,B.1.26,130,,
486,Multiple myeloma,410,Neoplasms,3,B.1.27,131,,
487,Leukemia,410,Neoplasms,3,B.1.28,132,,
845,Acute lymphoid leukemia,487,Leukemia,4,B.1.28.1,133,,
846,Chronic lymphoid leukemia,487,Leukemia,4,B.1.28.2,134,,
847,Acute myeloid leukemia,487,Leukemia,4,B.1.28.3,135,,
848,Chronic myeloid leukemia,487,Leukemia,4,B.1.28.4,136,,
943,Other leukemia,487,Leukemia,4,B.1.28.5,137,,
1022,Other malignant neoplasms,410,Neoplasms,3,B.1.29,138,,
490,Other neoplasms,410,Neoplasms,3,B.1.30,139,,
964,"Myelodysplastic, myeloproliferative, and other hematopoietic neoplasms",490,Other neoplasms,4,B.1.30.1,140,,
965,Benign and in situ intestinal neoplasms,490,Other neoplasms,4,B.1.30.2,141,,X
966,Benign and in situ cervical and uterine neoplasms,490,Other neoplasms,4,B.1.30.3,142,,X
967,Other benign and in situ neoplasms,490,Other neoplasms,4,B.1.30.4,143,,X
491,Cardiovascular diseases,409,Non-communicable diseases,2,B.2,144,,
492,Rheumatic heart disease,491,Cardiovascular diseases,3,B.2.1,145,,
493,Ischemic heart disease,491,Cardiovascular diseases,3,B.2.2,146,,
494,Stroke,491,Cardiovascular diseases,3,B.2.3,147,,
495,Ischemic stroke,494,Stroke,4,B.2.3.1,148,,
496,Intracerebral hemorrhage,494,Stroke,4,B.2.3.2,149,,
497,Subarachnoid hemorrhage,494,Stroke,4,B.2.3.3,150,,
498,Hypertensive heart disease,491,Cardiovascular diseases,3,B.2.4,151,,
504,Non-rheumatic valvular heart disease,491,Cardiovascular diseases,3,B.2.5,152,,
968,Non-rheumatic calcific aortic valve disease,504,Non-rheumatic valvular heart disease,4,B.2.5.1,153,,
969,Non-rheumatic degenerative mitral valve disease,504,Non-rheumatic valvular heart disease,4,B.2.5.2,154,,
970,Other non-rheumatic valve diseases,504,Non-rheumatic valvular heart disease,4,B.2.5.3,155,,
499,Cardiomyopathy and myocarditis,491,Cardiovascular diseases,3,B.2.6,156,,
942,Myocarditis,499,Cardiomyopathy and myocarditis,4,B.2.6.1,157,,
938,Alcoholic cardiomyopathy,499,Cardiomyopathy and myocarditis,4,B.2.6.2,158,,
944,Other cardiomyopathy,499,Cardiomyopathy and myocarditis,4,B.2.6.3,159,,
500,Atrial fibrillation and flutter,491,Cardiovascular diseases,3,B.2.8,160,,
501,Aortic aneurysm,491,Cardiovascular diseases,3,B.2.9,161,X,
502,Peripheral artery disease,491,Cardiovascular diseases,3,B.2.10,162,,
503,Endocarditis,491,Cardiovascular diseases,3,B.2.11,163,,
1023,Other cardiovascular and circulatory diseases,491,Cardiovascular diseases,3,B.2.12,164,,
508,Chronic respiratory diseases,409,Non-communicable diseases,2,B.3,165,,
509,Chronic obstructive pulmonary disease,508,Chronic respiratory diseases,3,B.3.1,166,,
510,Pneumoconiosis,508,Chronic respiratory diseases,3,B.3.2,167,,
511,Silicosis,510,Pneumoconiosis,4,B.3.2.1,168,,
512,Asbestosis,510,Pneumoconiosis,4,B.3.2.2,169,,
513,Coal workers pneumoconiosis,510,Pneumoconiosis,4,B.3.2.3,170,,
514,Other pneumoconiosis,510,Pneumoconiosis,4,B.3.2.4,171,,
515,Asthma,508,Chronic respiratory diseases,3,B.3.3,172,,
516,Interstitial lung disease and pulmonary sarcoidosis,508,Chronic respiratory diseases,3,B.3.4,173,,
520,Other chronic respiratory diseases,508,Chronic respiratory diseases,3,B.3.5,174,,
526,Digestive diseases,409,Non-communicable diseases,2,B.4,175,,
521,Cirrhosis and other chronic liver diseases,526,Digestive diseases,3,B.4.1,176,,
522,Cirrhosis and other chronic liver diseases due to hepatitis B,521,Cirrhosis and other chronic liver diseases,4,B.4.1.1,177,,
523,Cirrhosis and other chronic liver diseases due to hepatitis C,521,Cirrhosis and other chronic liver diseases,4,B.4.1.2,178,,
524,Cirrhosis and other chronic liver diseases due to alcohol use,521,Cirrhosis and other chronic liver diseases,4,B.4.1.3,179,,
971,Cirrhosis and other chronic liver diseases due to NAFLD,521,Cirrhosis and other chronic liver diseases,4,B.4.1.4,180,,
525,Cirrhosis and other chronic liver diseases due to other causes,521,Cirrhosis and other chronic liver diseases,4,B.4.1.5,181,,
992,Upper digestive system diseases,526,Digestive diseases,3,B.4.2,182,,
527,Peptic ulcer disease,992,Upper digestive system diseases,4,B.4.2.1,183,,
528,Gastritis and duodenitis,992,Upper digestive system diseases,4,B.4.2.2,184,,
536,Gastroesophageal reflux disease,992,Upper digestive system diseases,4,B.4.2.3,185,,X
529,Appendicitis,526,Digestive diseases,3,B.4.3,186,,
530,Paralytic ileus and intestinal obstruction,526,Digestive diseases,3,B.4.4,187,,
531,"Inguinal, femoral, and abdominal hernia",526,Digestive diseases,3,B.4.5,188,,
532,Inflammatory bowel disease,526,Digestive diseases,3,B.4.6,189,,
533,Vascular intestinal disorders,526,Digestive diseases,3,B.4.7,190,,
534,Gallbladder and biliary diseases,526,Digestive diseases,3,B.4.8,191,,
535,Pancreatitis,526,Digestive diseases,3,B.4.9,192,,
541,Other digestive diseases,526,Digestive diseases,3,B.4.10,193,,
542,Neurological disorders,409,Non-communicable diseases,2,B.5,194,,
543,Alzheimer's disease and other dementias,542,Neurological disorders,3,B.5.1,195,,
544,Parkinson's disease,542,Neurological disorders,3,B.5.2,196,,
545,Idiopathic epilepsy,542,Neurological disorders,3,B.5.3,197,,
546,Multiple sclerosis,542,Neurological disorders,3,B.5.4,198,,
554,Motor neuron disease,542,Neurological disorders,3,B.5.5,199,,
972,Headache disorders,542,Neurological disorders,3,B.5.6,200,,X
547,Migraine,972,Headache disorders,4,B.5.6.1,201,,X
548,Tension-type headache,972,Headache disorders,4,B.5.6.2,202,,X
557,Other neurological disorders,542,Neurological disorders,3,B.5.7,203,,
558,Mental disorders,409,Non-communicable diseases,2,B.6,204,,
559,Schizophrenia,558,Mental disorders,3,B.6.1,205,,X
567,Depressive disorders,558,Mental disorders,3,B.6.2,206,,X
568,Major depressive disorder,567,Depressive disorders,4,B.6.2.1,207,,X
569,Dysthymia,567,Depressive disorders,4,B.6.2.2,208,,X
570,Bipolar disorder,558,Mental disorders,3,B.6.3,209,,X
571,Anxiety disorders,558,Mental disorders,3,B.6.4,210,,X
572,Eating disorders,558,Mental disorders,3,B.6.5,211,,
573,Anorexia nervosa,572,Eating disorders,4,B.6.5.1,212,,
574,Bulimia nervosa,572,Eating disorders,4,B.6.5.2,213,,
575,Autism spectrum disorders,558,Mental disorders,3,B.6.6,214,,X
578,Attention-deficit/hyperactivity disorder,558,Mental disorders,3,B.6.7,215,,X
579,Conduct disorder,558,Mental disorders,3,B.6.8,216,,X
582,Idiopathic developmental intellectual disability,558,Mental disorders,3,B.6.9,217,,X
585,Other mental disorders,558,Mental disorders,3,B.6.10,218,,X
973,Substance use disorders,409,Non-communicable diseases,2,B.7,219,,
560,Alcohol use disorders,973,Substance use disorders,3,B.7.1,220,,
561,Drug use disorders,973,Substance use disorders,3,B.7.2,221,,
562,Opioid use disorders,561,Drug use disorders,4,B.7.2.1,222,,
563,Cocaine use disorders,561,Drug use disorders,4,B.7.2.2,223,,
564,Amphetamine use disorders,561,Drug use disorders,4,B.7.2.3,224,,
565,Cannabis use disorders,561,Drug use disorders,4,B.7.2.4,225,,X
566,Other drug use disorders,561,Drug use disorders,4,B.7.2.5,226,,
974,Diabetes and kidney diseases,409,Non-communicable diseases,2,B.8,227,,
587,Diabetes mellitus,974,Diabetes and kidney diseases,3,B.8.1,228,,
975,Diabetes mellitus type 1,587,Diabetes mellitus,4,B.8.1.1,229,,
976,Diabetes mellitus type 2,587,Diabetes mellitus,4,B.8.1.2,230,,
589,Chronic kidney disease,974,Diabetes and kidney diseases,3,B.8.2,231,,
997,Chronic kidney disease due to diabetes mellitus type 1,589,Chronic kidney disease,4,B.8.2.1,232,,
998,Chronic kidney disease due to diabetes mellitus type 2,589,Chronic kidney disease,4,B.8.2.2,233,,
591,Chronic kidney disease due to hypertension,589,Chronic kidney disease,4,B.8.2.3,234,,
592,Chronic kidney disease due to glomerulonephritis,589,Chronic kidney disease,4,B.8.2.4,235,,
593,Chronic kidney disease due to other and unspecified causes,589,Chronic kidney disease,4,B.8.2.5,236,,
588,Acute glomerulonephritis,974,Diabetes and kidney diseases,3,B.8.3,237,,
653,Skin and subcutaneous diseases,409,Non-communicable diseases,2,B.9,238,,
654,Dermatitis,653,Skin and subcutaneous diseases,3,B.9.1,239,,X
977,Atopic dermatitis,654,Dermatitis,4,B.9.1.1,240,,X
978,Contact dermatitis,654,Dermatitis,4,B.9.1.2,241,,X
979,Seborrhoeic dermatitis,654,Dermatitis,4,B.9.1.3,242,,X
655,Psoriasis,653,Skin and subcutaneous diseases,3,B.9.2,243,,X
980,Bacterial skin diseases,653,Skin and subcutaneous diseases,3,B.9.3,244,,
656,Cellulitis,980,Bacterial skin diseases,4,B.9.3.1,245,,
657,Pyoderma,980,Bacterial skin diseases,4,B.9.3.2,246,,
658,Scabies,653,Skin and subcutaneous diseases,3,B.9.4,247,,X
659,Fungal skin diseases,653,Skin and subcutaneous diseases,3,B.9.5,248,,X
660,Viral skin diseases,653,Skin and subcutaneous diseases,3,B.9.6,249,,X
661,Acne vulgaris,653,Skin and subcutaneous diseases,3,B.9.7,250,,X
662,Alopecia areata,653,Skin and subcutaneous diseases,3,B.9.8,251,,X
663,Pruritus,653,Skin and subcutaneous diseases,3,B.9.9,252,,X
664,Urticaria,653,Skin and subcutaneous diseases,3,B.9.10,253,,X
665,Decubitus ulcer,653,Skin and subcutaneous diseases,3,B.9.11,254,,
668,Other skin and subcutaneous diseases,653,Skin and subcutaneous diseases,3,B.9.12,255,,
669,Sense organ diseases,409,Non-communicable diseases,2,B.10,256,,X
981,Blindness and vision loss,669,Sense organ diseases,3,B.10.1,257,,X
670,Glaucoma,981,Blindness and vision loss,4,B.10.1.1,258,,X
671,Cataract,981,Blindness and vision loss,4,B.10.1.2,259,,X
672,Age-related macular degeneration,981,Blindness and vision loss,4,B.10.1.3,260,,X
999,Refraction disorders,981,Blindness and vision loss,4,B.10.1.4,261,,X
1000,Near vision loss,981,Blindness and vision loss,4,B.10.1.5,262,,X
675,Other vision loss,981,Blindness and vision loss,4,B.10.1.6,263,,X
674,Age-related and other hearing loss,669,Sense organ diseases,3,B.10.2,264,,X
679,Other sense organ diseases,669,Sense organ diseases,3,B.10.3,265,,X
626,Musculoskeletal disorders,409,Non-communicable diseases,2,B.11,266,,
627,Rheumatoid arthritis,626,Musculoskeletal disorders,3,B.11.1,267,,
628,Osteoarthritis,626,Musculoskeletal disorders,3,B.11.2,268,,X
1014,Osteoarthritis hip,628,Osteoarthritis,4,B.11.2.1,269,,X
1015,Osteoarthritis knee,628,Osteoarthritis,4,B.11.2.2,270,,X
1016,Osteoarthritis hand,628,Osteoarthritis,4,B.11.2.3,271,,X
1017,Osteoarthritis other,628,Osteoarthritis,4,B.11.2.4,272,,X
630,Low back pain,626,Musculoskeletal disorders,3,B.11.3,273,,X
631,Neck pain,626,Musculoskeletal disorders,3,B.11.4,274,,X
632,Gout,626,Musculoskeletal disorders,3,B.11.5,275,,X
639,Other musculoskeletal disorders,626,Musculoskeletal disorders,3,B.11.6,276,,
640,Other non-communicable diseases,409,Non-communicable diseases,2,B.12,277,,
641,Congenital birth defects,640,Other non-communicable diseases,3,B.12.1,278,,
642,Neural tube defects,641,Congenital birth defects,4,B.12.1.1,279,,
643,Congenital heart anomalies,641,Congenital birth defects,4,B.12.1.2,280,,
644,Orofacial clefts,641,Congenital birth defects,4,B.12.1.3,281,,
645,Down syndrome,641,Congenital birth defects,4,B.12.1.4,282,,
646,Turner syndrome,641,Congenital birth defects,4,B.12.1.5,283,,X
647,Klinefelter syndrome,641,Congenital birth defects,4,B.12.1.6,284,,X
648,Other chromosomal abnormalities,641,Congenital birth defects,4,B.12.1.7,285,,
649,Congenital musculoskeletal and limb anomalies,641,Congenital birth defects,4,B.12.1.8,286,,
650,Urogenital congenital anomalies,641,Congenital birth defects,4,B.12.1.9,287,,
651,Digestive congenital anomalies,641,Congenital birth defects,4,B.12.1.10,288,,
652,Other congenital birth defects,641,Congenital birth defects,4,B.12.1.11,289,,
594,Urinary diseases and male infertility,640,Other non-communicable diseases,3,B.12.2,290,,
595,Urinary tract infections and interstitial nephritis,594,Urinary diseases and male infertility,4,B.12.2.1,291,,
596,Urolithiasis,594,Urinary diseases and male infertility,4,B.12.2.2,292,,
597,Benign prostatic hyperplasia,594,Urinary diseases and male infertility,4,B.12.2.3,293,,X
598,Male infertility,594,Urinary diseases and male infertility,4,B.12.2.4,294,,X
602,Other urinary diseases,594,Urinary diseases and male infertility,4,B.12.2.5,295,,
603,Gynecological diseases,640,Other non-communicable diseases,3,B.12.3,296,,
604,Uterine fibroids,603,Gynecological diseases,4,B.12.3.1,297,,
605,Polycystic ovarian syndrome,603,Gynecological diseases,4,B.12.3.2,298,,X
606,Female infertility,603,Gynecological diseases,4,B.12.3.3,299,,X
607,Endometriosis,603,Gynecological diseases,4,B.12.3.4,300,,
608,Genital prolapse,603,Gynecological diseases,4,B.12.3.5,301,,
609,Premenstrual syndrome,603,Gynecological diseases,4,B.12.3.6,302,,X
612,Other gynecological diseases,603,Gynecological diseases,4,B.12.3.7,303,,
613,Hemoglobinopathies and hemolytic anemias,640,Other non-communicable diseases,3,B.12.4,304,,
614,Thalassemias,613,Hemoglobinopathies and hemolytic anemias,4,B.12.4.1,305,,
837,Thalassemias trait,613,Hemoglobinopathies and hemolytic anemias,4,B.12.4.2,306,,X
615,Sickle cell disorders,613,Hemoglobinopathies and hemolytic anemias,4,B.12.4.3,307,,
838,Sickle cell trait,613,Hemoglobinopathies and hemolytic anemias,4,B.12.4.4,308,,X
616,G6PD deficiency,613,Hemoglobinopathies and hemolytic anemias,4,B.12.4.5,309,,
839,G6PD trait,613,Hemoglobinopathies and hemolytic anemias,4,B.12.4.6,310,,X
618,Other hemoglobinopathies and hemolytic anemias,613,Hemoglobinopathies and hemolytic anemias,4,B.12.4.7,311,,
619,"Endocrine, metabolic, blood, and immune disorders",640,Other non-communicable diseases,3,B.12.5,312,,
680,Oral disorders,640,Other non-communicable diseases,3,B.12.6,313,,X
681,Caries of deciduous teeth,680,Oral disorders,4,B.12.6.1,314,,X
682,Caries of permanent teeth,680,Oral disorders,4,B.12.6.2,315,,X
683,Periodontal diseases,680,Oral disorders,4,B.12.6.3,316,,X
684,Edentulism,680,Oral disorders,4,B.12.6.4,317,,X
685,Other oral disorders,680,Oral disorders,4,B.12.6.5,318,,X
686,Sudden infant death syndrome,640,Other non-communicable diseases,3,B.12.7,319,X,
687,Injuries,294,All causes,1,C,320,,
688,Transport injuries,687,Injuries,2,C.1,321,,
689,Road injuries,688,Transport injuries,3,C.1.1,322,,
690,Pedestrian road injuries,689,Road injuries,4,C.1.1.1,323,,
691,Cyclist road injuries,689,Road injuries,4,C.1.1.2,324,,
692,Motorcyclist road injuries,689,Road injuries,4,C.1.1.3,325,,
693,Motor vehicle road injuries,689,Road injuries,4,C.1.1.4,326,,
694,Other road injuries,689,Road injuries,4,C.1.1.5,327,,
695,Other transport injuries,688,Transport injuries,3,C.1.2,328,,
696,Unintentional injuries,687,Injuries,2,C.2,329,,
697,Falls,696,Unintentional injuries,3,C.2.1,330,,
698,Drowning,696,Unintentional injuries,3,C.2.2,331,,
699,"Fire, heat, and hot substances",696,Unintentional injuries,3,C.2.3,332,,
700,Poisonings,696,Unintentional injuries,3,C.2.4,333,,
701,Poisoning by carbon monoxide,700,Poisonings,4,C.2.4.1,334,,
703,Poisoning by other means,700,Poisonings,4,C.2.4.2,335,,
704,Exposure to mechanical forces,696,Unintentional injuries,3,C.2.5,336,,
705,Unintentional firearm injuries,704,Exposure to mechanical forces,4,C.2.5.1,337,,
707,Other exposure to mechanical forces,704,Exposure to mechanical forces,4,C.2.5.2,338,,
708,Adverse effects of medical treatment,696,Unintentional injuries,3,C.2.6,339,,
709,Animal contact,696,Unintentional injuries,3,C.2.7,340,,
710,Venomous animal contact,709,Animal contact,4,C.2.7.1,341,,
711,Non-venomous animal contact,709,Animal contact,4,C.2.7.2,342,,
712,Foreign body,696,Unintentional injuries,3,C.2.8,343,,
713,Pulmonary aspiration and foreign body in airway,712,Foreign body,4,C.2.8.1,344,,
714,Foreign body in eyes,712,Foreign body,4,C.2.8.2,345,,X
715,Foreign body in other body part,712,Foreign body,4,C.2.8.3,346,,
842,Environmental heat and cold exposure,696,Unintentional injuries,3,C.2.9,347,,
729,Exposure to forces of nature,696,Unintentional injuries,3,C.2.10,348,,
716,Other unintentional injuries,696,Unintentional injuries,3,C.2.11,349,,
717,Self-harm and interpersonal violence,687,Injuries,2,C.3,350,,
718,Self-harm,717,Self-harm and interpersonal violence,3,C.3.1,351,,
721,Self-harm by firearm,718,Self-harm,4,C.3.1.1,352,,
723,Self-harm by other specified means,718,Self-harm,4,C.3.1.2,353,,
724,Interpersonal violence,717,Self-harm and interpersonal violence,3,C.3.2,354,,
725,Physical violence by firearm,724,Interpersonal violence,4,C.3.2.1,355,,
726,Physical violence by sharp object,724,Interpersonal violence,4,C.3.2.2,356,,
941,Sexual violence,724,Interpersonal violence,4,C.3.2.3,357,,X
727,Physical violence by other means,724,Interpersonal violence,4,C.3.2.4,358,,
945,Conflict and terrorism,717,Self-harm and interpersonal violence,3,C.3.3,359,,
854,Executions and police conflict,717,Self-harm and interpersonal violence,3,C.3.4,360,,
1029,Total cancers,294,All causes,1,D,361,,
1026,Total burden related to hepatitis B,294,All causes,1,E,362,,
1027,Total burden related to hepatitis C,294,All causes,1,F,363,,
1028,Total burden related to Non-alcoholic fatty liver disease (NAFLD),294,All causes,1,G,364,,
1 Cause ID Cause Name Parent ID Parent Name Level Cause Outline Sort Order YLL Only YLD Only
2 294 All causes 294 All causes 0 Total 1
3 295 Communicable, maternal, neonatal, and nutritional diseases 294 All causes 1 A 2
4 955 HIV/AIDS and sexually transmitted infections 295 Communicable, maternal, neonatal, and nutritional diseases 2 A.1 3
5 298 HIV/AIDS 955 HIV/AIDS and sexually transmitted infections 3 A.1.1 4
6 948 HIV/AIDS - Drug-susceptible Tuberculosis 298 HIV/AIDS 4 A.1.1.1 5
7 949 HIV/AIDS - Multidrug-resistant Tuberculosis without extensive drug resistance 298 HIV/AIDS 4 A.1.1.2 6
8 950 HIV/AIDS - Extensively drug-resistant Tuberculosis 298 HIV/AIDS 4 A.1.1.3 7
9 300 HIV/AIDS resulting in other diseases 298 HIV/AIDS 4 A.1.1.4 8
10 393 Sexually transmitted infections excluding HIV 955 HIV/AIDS and sexually transmitted infections 3 A.1.2 9
11 394 Syphilis 393 Sexually transmitted infections excluding HIV 4 A.1.2.1 10
12 395 Chlamydial infection 393 Sexually transmitted infections excluding HIV 4 A.1.2.2 11
13 396 Gonococcal infection 393 Sexually transmitted infections excluding HIV 4 A.1.2.3 12
14 397 Trichomoniasis 393 Sexually transmitted infections excluding HIV 4 A.1.2.4 13 X
15 398 Genital herpes 393 Sexually transmitted infections excluding HIV 4 A.1.2.5 14 X
16 399 Other sexually transmitted infections 393 Sexually transmitted infections excluding HIV 4 A.1.2.6 15
17 956 Respiratory infections and tuberculosis 295 Communicable, maternal, neonatal, and nutritional diseases 2 A.2 16
18 297 Tuberculosis 956 Respiratory infections and tuberculosis 3 A.2.1 17
19 954 Latent tuberculosis infection 297 Tuberculosis 4 A.2.1.1 18 X
20 934 Drug-susceptible tuberculosis 297 Tuberculosis 4 A.2.1.2 19
21 946 Multidrug-resistant tuberculosis without extensive drug resistance 297 Tuberculosis 4 A.2.1.3 20
22 947 Extensively drug-resistant tuberculosis 297 Tuberculosis 4 A.2.1.4 21
23 322 Lower respiratory infections 956 Respiratory infections and tuberculosis 3 A.2.2 22
24 328 Upper respiratory infections 956 Respiratory infections and tuberculosis 3 A.2.3 23
25 329 Otitis media 956 Respiratory infections and tuberculosis 3 A.2.4 24
26 957 Enteric infections 295 Communicable, maternal, neonatal, and nutritional diseases 2 A.3 25
27 302 Diarrheal diseases 957 Enteric infections 3 A.3.1 26
28 958 Typhoid and paratyphoid 957 Enteric infections 3 A.3.2 27
29 319 Typhoid fever 958 Typhoid and paratyphoid 4 A.3.2.1 28
30 320 Paratyphoid fever 958 Typhoid and paratyphoid 4 A.3.2.2 29
31 959 Invasive Non-typhoidal Salmonella (iNTS) 957 Enteric infections 3 A.3.3 30
32 321 Other intestinal infectious diseases 957 Enteric infections 3 A.3.4 31
33 344 Neglected tropical diseases and malaria 295 Communicable, maternal, neonatal, and nutritional diseases 2 A.4 32
34 345 Malaria 344 Neglected tropical diseases and malaria 3 A.4.1 33
35 346 Chagas disease 344 Neglected tropical diseases and malaria 3 A.4.2 34
36 347 Leishmaniasis 344 Neglected tropical diseases and malaria 3 A.4.3 35
37 348 Visceral leishmaniasis 347 Leishmaniasis 4 A.4.3.1 36
38 349 Cutaneous and mucocutaneous leishmaniasis 347 Leishmaniasis 4 A.4.3.2 37 X
39 350 African trypanosomiasis 344 Neglected tropical diseases and malaria 3 A.4.4 38
40 351 Schistosomiasis 344 Neglected tropical diseases and malaria 3 A.4.5 39
41 352 Cysticercosis 344 Neglected tropical diseases and malaria 3 A.4.6 40
42 353 Cystic echinococcosis 344 Neglected tropical diseases and malaria 3 A.4.7 41
43 354 Lymphatic filariasis 344 Neglected tropical diseases and malaria 3 A.4.8 42 X
44 355 Onchocerciasis 344 Neglected tropical diseases and malaria 3 A.4.9 43 X
45 356 Trachoma 344 Neglected tropical diseases and malaria 3 A.4.10 44 X
46 357 Dengue 344 Neglected tropical diseases and malaria 3 A.4.11 45
47 358 Yellow fever 344 Neglected tropical diseases and malaria 3 A.4.12 46
48 359 Rabies 344 Neglected tropical diseases and malaria 3 A.4.13 47
49 360 Intestinal nematode infections 344 Neglected tropical diseases and malaria 3 A.4.14 48
50 361 Ascariasis 360 Intestinal nematode infections 4 A.4.14.1 49
51 362 Trichuriasis 360 Intestinal nematode infections 4 A.4.14.2 50 X
52 363 Hookworm disease 360 Intestinal nematode infections 4 A.4.14.3 51 X
53 364 Food-borne trematodiases 344 Neglected tropical diseases and malaria 3 A.4.15 52 X
54 405 Leprosy 344 Neglected tropical diseases and malaria 3 A.4.16 53 X
55 843 Ebola 344 Neglected tropical diseases and malaria 3 A.4.17 54
56 935 Zika virus 344 Neglected tropical diseases and malaria 3 A.4.18 55
57 936 Guinea worm disease 344 Neglected tropical diseases and malaria 3 A.4.19 56 X
58 365 Other neglected tropical diseases 344 Neglected tropical diseases and malaria 3 A.4.20 57
59 961 Other infectious diseases 295 Communicable, maternal, neonatal, and nutritional diseases 2 A.5 58
60 332 Meningitis 961 Other infectious diseases 3 A.5.1 59
61 337 Encephalitis 961 Other infectious diseases 3 A.5.2 60
62 338 Diphtheria 961 Other infectious diseases 3 A.5.3 61
63 339 Whooping cough 961 Other infectious diseases 3 A.5.4 62
64 340 Tetanus 961 Other infectious diseases 3 A.5.5 63
65 341 Measles 961 Other infectious diseases 3 A.5.6 64
66 342 Varicella and herpes zoster 961 Other infectious diseases 3 A.5.7 65
67 400 Acute hepatitis 961 Other infectious diseases 3 A.5.8 66
68 401 Acute hepatitis A 400 Acute hepatitis 4 A.5.8.1 67
69 402 Acute hepatitis B 400 Acute hepatitis 4 A.5.8.2 68
70 403 Acute hepatitis C 400 Acute hepatitis 4 A.5.8.3 69
71 404 Acute hepatitis E 400 Acute hepatitis 4 A.5.8.4 70
72 408 Other unspecified infectious diseases 961 Other infectious diseases 3 A.5.9 71
73 962 Maternal and neonatal disorders 295 Communicable, maternal, neonatal, and nutritional diseases 2 A.6 72
74 366 Maternal disorders 962 Maternal and neonatal disorders 3 A.6.1 73
75 367 Maternal hemorrhage 366 Maternal disorders 4 A.6.1.1 74
76 368 Maternal sepsis and other maternal infections 366 Maternal disorders 4 A.6.1.2 75
77 369 Maternal hypertensive disorders 366 Maternal disorders 4 A.6.1.3 76
78 370 Maternal obstructed labor and uterine rupture 366 Maternal disorders 4 A.6.1.4 77
79 995 Maternal abortion and miscarriage 366 Maternal disorders 4 A.6.1.5 78
80 374 Ectopic pregnancy 366 Maternal disorders 4 A.6.1.6 79
81 375 Indirect maternal deaths 366 Maternal disorders 4 A.6.1.7 80 X
82 376 Late maternal deaths 366 Maternal disorders 4 A.6.1.8 81 X
83 741 Maternal deaths aggravated by HIV/AIDS 366 Maternal disorders 4 A.6.1.9 82 X
84 379 Other maternal disorders 366 Maternal disorders 4 A.6.1.10 83
85 380 Neonatal disorders 962 Maternal and neonatal disorders 3 A.6.2 84
86 381 Neonatal preterm birth 380 Neonatal disorders 4 A.6.2.1 85
87 382 Neonatal encephalopathy due to birth asphyxia and trauma 380 Neonatal disorders 4 A.6.2.2 86
88 383 Neonatal sepsis and other neonatal infections 380 Neonatal disorders 4 A.6.2.3 87
89 384 Hemolytic disease and other neonatal jaundice 380 Neonatal disorders 4 A.6.2.4 88
90 385 Other neonatal disorders 380 Neonatal disorders 4 A.6.2.5 89
91 386 Nutritional deficiencies 295 Communicable, maternal, neonatal, and nutritional diseases 2 A.7 90
92 387 Protein-energy malnutrition 386 Nutritional deficiencies 3 A.7.1 91
93 388 Iodine deficiency 386 Nutritional deficiencies 3 A.7.2 92 X
94 389 Vitamin A deficiency 386 Nutritional deficiencies 3 A.7.3 93 X
95 390 Dietary iron deficiency 386 Nutritional deficiencies 3 A.7.4 94 X
96 391 Other nutritional deficiencies 386 Nutritional deficiencies 3 A.7.5 95
97 409 Non-communicable diseases 294 All causes 1 B 96
98 410 Neoplasms 409 Non-communicable diseases 2 B.1 97
99 444 Lip and oral cavity cancer 410 Neoplasms 3 B.1.1 98
100 447 Nasopharynx cancer 410 Neoplasms 3 B.1.2 99
101 450 Other pharynx cancer 410 Neoplasms 3 B.1.3 100
102 411 Esophageal cancer 410 Neoplasms 3 B.1.4 101
103 414 Stomach cancer 410 Neoplasms 3 B.1.5 102
104 441 Colon and rectum cancer 410 Neoplasms 3 B.1.6 103
105 417 Liver cancer 410 Neoplasms 3 B.1.7 104
106 418 Liver cancer due to hepatitis B 417 Liver cancer 4 B.1.7.1 105
107 419 Liver cancer due to hepatitis C 417 Liver cancer 4 B.1.7.2 106
108 420 Liver cancer due to alcohol use 417 Liver cancer 4 B.1.7.3 107
109 996 Liver cancer due to NASH 417 Liver cancer 4 B.1.7.4 108
110 1021 Liver cancer due to other causes 417 Liver cancer 4 B.1.7.5 109
111 453 Gallbladder and biliary tract cancer 410 Neoplasms 3 B.1.8 110
112 456 Pancreatic cancer 410 Neoplasms 3 B.1.9 111
113 423 Larynx cancer 410 Neoplasms 3 B.1.10 112
114 426 Tracheal, bronchus, and lung cancer 410 Neoplasms 3 B.1.11 113
115 459 Malignant skin melanoma 410 Neoplasms 3 B.1.12 114
116 462 Non-melanoma skin cancer 410 Neoplasms 3 B.1.13 115
117 849 Non-melanoma skin cancer (squamous-cell carcinoma) 462 Non-melanoma skin cancer 4 B.1.13.1 116
118 850 Non-melanoma skin cancer (basal-cell carcinoma) 462 Non-melanoma skin cancer 4 B.1.13.2 117 X
119 429 Breast cancer 410 Neoplasms 3 B.1.14 118
120 432 Cervical cancer 410 Neoplasms 3 B.1.15 119
121 435 Uterine cancer 410 Neoplasms 3 B.1.16 120
122 465 Ovarian cancer 410 Neoplasms 3 B.1.17 121
123 438 Prostate cancer 410 Neoplasms 3 B.1.18 122
124 468 Testicular cancer 410 Neoplasms 3 B.1.19 123
125 471 Kidney cancer 410 Neoplasms 3 B.1.20 124
126 474 Bladder cancer 410 Neoplasms 3 B.1.21 125
127 477 Brain and central nervous system cancer 410 Neoplasms 3 B.1.22 126
128 480 Thyroid cancer 410 Neoplasms 3 B.1.23 127
129 483 Mesothelioma 410 Neoplasms 3 B.1.24 128
130 484 Hodgkin lymphoma 410 Neoplasms 3 B.1.25 129
131 485 Non-Hodgkin lymphoma 410 Neoplasms 3 B.1.26 130
132 486 Multiple myeloma 410 Neoplasms 3 B.1.27 131
133 487 Leukemia 410 Neoplasms 3 B.1.28 132
134 845 Acute lymphoid leukemia 487 Leukemia 4 B.1.28.1 133
135 846 Chronic lymphoid leukemia 487 Leukemia 4 B.1.28.2 134
136 847 Acute myeloid leukemia 487 Leukemia 4 B.1.28.3 135
137 848 Chronic myeloid leukemia 487 Leukemia 4 B.1.28.4 136
138 943 Other leukemia 487 Leukemia 4 B.1.28.5 137
139 1022 Other malignant neoplasms 410 Neoplasms 3 B.1.29 138
140 490 Other neoplasms 410 Neoplasms 3 B.1.30 139
141 964 Myelodysplastic, myeloproliferative, and other hematopoietic neoplasms 490 Other neoplasms 4 B.1.30.1 140
142 965 Benign and in situ intestinal neoplasms 490 Other neoplasms 4 B.1.30.2 141 X
143 966 Benign and in situ cervical and uterine neoplasms 490 Other neoplasms 4 B.1.30.3 142 X
144 967 Other benign and in situ neoplasms 490 Other neoplasms 4 B.1.30.4 143 X
145 491 Cardiovascular diseases 409 Non-communicable diseases 2 B.2 144
146 492 Rheumatic heart disease 491 Cardiovascular diseases 3 B.2.1 145
147 493 Ischemic heart disease 491 Cardiovascular diseases 3 B.2.2 146
148 494 Stroke 491 Cardiovascular diseases 3 B.2.3 147
149 495 Ischemic stroke 494 Stroke 4 B.2.3.1 148
150 496 Intracerebral hemorrhage 494 Stroke 4 B.2.3.2 149
151 497 Subarachnoid hemorrhage 494 Stroke 4 B.2.3.3 150
152 498 Hypertensive heart disease 491 Cardiovascular diseases 3 B.2.4 151
153 504 Non-rheumatic valvular heart disease 491 Cardiovascular diseases 3 B.2.5 152
154 968 Non-rheumatic calcific aortic valve disease 504 Non-rheumatic valvular heart disease 4 B.2.5.1 153
155 969 Non-rheumatic degenerative mitral valve disease 504 Non-rheumatic valvular heart disease 4 B.2.5.2 154
156 970 Other non-rheumatic valve diseases 504 Non-rheumatic valvular heart disease 4 B.2.5.3 155
157 499 Cardiomyopathy and myocarditis 491 Cardiovascular diseases 3 B.2.6 156
158 942 Myocarditis 499 Cardiomyopathy and myocarditis 4 B.2.6.1 157
159 938 Alcoholic cardiomyopathy 499 Cardiomyopathy and myocarditis 4 B.2.6.2 158
160 944 Other cardiomyopathy 499 Cardiomyopathy and myocarditis 4 B.2.6.3 159
161 500 Atrial fibrillation and flutter 491 Cardiovascular diseases 3 B.2.8 160
162 501 Aortic aneurysm 491 Cardiovascular diseases 3 B.2.9 161 X
163 502 Peripheral artery disease 491 Cardiovascular diseases 3 B.2.10 162
164 503 Endocarditis 491 Cardiovascular diseases 3 B.2.11 163
165 1023 Other cardiovascular and circulatory diseases 491 Cardiovascular diseases 3 B.2.12 164
166 508 Chronic respiratory diseases 409 Non-communicable diseases 2 B.3 165
167 509 Chronic obstructive pulmonary disease 508 Chronic respiratory diseases 3 B.3.1 166
168 510 Pneumoconiosis 508 Chronic respiratory diseases 3 B.3.2 167
169 511 Silicosis 510 Pneumoconiosis 4 B.3.2.1 168
170 512 Asbestosis 510 Pneumoconiosis 4 B.3.2.2 169
171 513 Coal workers pneumoconiosis 510 Pneumoconiosis 4 B.3.2.3 170
172 514 Other pneumoconiosis 510 Pneumoconiosis 4 B.3.2.4 171
173 515 Asthma 508 Chronic respiratory diseases 3 B.3.3 172
174 516 Interstitial lung disease and pulmonary sarcoidosis 508 Chronic respiratory diseases 3 B.3.4 173
175 520 Other chronic respiratory diseases 508 Chronic respiratory diseases 3 B.3.5 174
176 526 Digestive diseases 409 Non-communicable diseases 2 B.4 175
177 521 Cirrhosis and other chronic liver diseases 526 Digestive diseases 3 B.4.1 176
178 522 Cirrhosis and other chronic liver diseases due to hepatitis B 521 Cirrhosis and other chronic liver diseases 4 B.4.1.1 177
179 523 Cirrhosis and other chronic liver diseases due to hepatitis C 521 Cirrhosis and other chronic liver diseases 4 B.4.1.2 178
180 524 Cirrhosis and other chronic liver diseases due to alcohol use 521 Cirrhosis and other chronic liver diseases 4 B.4.1.3 179
181 971 Cirrhosis and other chronic liver diseases due to NAFLD 521 Cirrhosis and other chronic liver diseases 4 B.4.1.4 180
182 525 Cirrhosis and other chronic liver diseases due to other causes 521 Cirrhosis and other chronic liver diseases 4 B.4.1.5 181
183 992 Upper digestive system diseases 526 Digestive diseases 3 B.4.2 182
184 527 Peptic ulcer disease 992 Upper digestive system diseases 4 B.4.2.1 183
185 528 Gastritis and duodenitis 992 Upper digestive system diseases 4 B.4.2.2 184
186 536 Gastroesophageal reflux disease 992 Upper digestive system diseases 4 B.4.2.3 185 X
187 529 Appendicitis 526 Digestive diseases 3 B.4.3 186
188 530 Paralytic ileus and intestinal obstruction 526 Digestive diseases 3 B.4.4 187
189 531 Inguinal, femoral, and abdominal hernia 526 Digestive diseases 3 B.4.5 188
190 532 Inflammatory bowel disease 526 Digestive diseases 3 B.4.6 189
191 533 Vascular intestinal disorders 526 Digestive diseases 3 B.4.7 190
192 534 Gallbladder and biliary diseases 526 Digestive diseases 3 B.4.8 191
193 535 Pancreatitis 526 Digestive diseases 3 B.4.9 192
194 541 Other digestive diseases 526 Digestive diseases 3 B.4.10 193
195 542 Neurological disorders 409 Non-communicable diseases 2 B.5 194
196 543 Alzheimer's disease and other dementias 542 Neurological disorders 3 B.5.1 195
197 544 Parkinson's disease 542 Neurological disorders 3 B.5.2 196
198 545 Idiopathic epilepsy 542 Neurological disorders 3 B.5.3 197
199 546 Multiple sclerosis 542 Neurological disorders 3 B.5.4 198
200 554 Motor neuron disease 542 Neurological disorders 3 B.5.5 199
201 972 Headache disorders 542 Neurological disorders 3 B.5.6 200 X
202 547 Migraine 972 Headache disorders 4 B.5.6.1 201 X
203 548 Tension-type headache 972 Headache disorders 4 B.5.6.2 202 X
204 557 Other neurological disorders 542 Neurological disorders 3 B.5.7 203
205 558 Mental disorders 409 Non-communicable diseases 2 B.6 204
206 559 Schizophrenia 558 Mental disorders 3 B.6.1 205 X
207 567 Depressive disorders 558 Mental disorders 3 B.6.2 206 X
208 568 Major depressive disorder 567 Depressive disorders 4 B.6.2.1 207 X
209 569 Dysthymia 567 Depressive disorders 4 B.6.2.2 208 X
210 570 Bipolar disorder 558 Mental disorders 3 B.6.3 209 X
211 571 Anxiety disorders 558 Mental disorders 3 B.6.4 210 X
212 572 Eating disorders 558 Mental disorders 3 B.6.5 211
213 573 Anorexia nervosa 572 Eating disorders 4 B.6.5.1 212
214 574 Bulimia nervosa 572 Eating disorders 4 B.6.5.2 213
215 575 Autism spectrum disorders 558 Mental disorders 3 B.6.6 214 X
216 578 Attention-deficit/hyperactivity disorder 558 Mental disorders 3 B.6.7 215 X
217 579 Conduct disorder 558 Mental disorders 3 B.6.8 216 X
218 582 Idiopathic developmental intellectual disability 558 Mental disorders 3 B.6.9 217 X
219 585 Other mental disorders 558 Mental disorders 3 B.6.10 218 X
220 973 Substance use disorders 409 Non-communicable diseases 2 B.7 219
221 560 Alcohol use disorders 973 Substance use disorders 3 B.7.1 220
222 561 Drug use disorders 973 Substance use disorders 3 B.7.2 221
223 562 Opioid use disorders 561 Drug use disorders 4 B.7.2.1 222
224 563 Cocaine use disorders 561 Drug use disorders 4 B.7.2.2 223
225 564 Amphetamine use disorders 561 Drug use disorders 4 B.7.2.3 224
226 565 Cannabis use disorders 561 Drug use disorders 4 B.7.2.4 225 X
227 566 Other drug use disorders 561 Drug use disorders 4 B.7.2.5 226
228 974 Diabetes and kidney diseases 409 Non-communicable diseases 2 B.8 227
229 587 Diabetes mellitus 974 Diabetes and kidney diseases 3 B.8.1 228
230 975 Diabetes mellitus type 1 587 Diabetes mellitus 4 B.8.1.1 229
231 976 Diabetes mellitus type 2 587 Diabetes mellitus 4 B.8.1.2 230
232 589 Chronic kidney disease 974 Diabetes and kidney diseases 3 B.8.2 231
233 997 Chronic kidney disease due to diabetes mellitus type 1 589 Chronic kidney disease 4 B.8.2.1 232
234 998 Chronic kidney disease due to diabetes mellitus type 2 589 Chronic kidney disease 4 B.8.2.2 233
235 591 Chronic kidney disease due to hypertension 589 Chronic kidney disease 4 B.8.2.3 234
236 592 Chronic kidney disease due to glomerulonephritis 589 Chronic kidney disease 4 B.8.2.4 235
237 593 Chronic kidney disease due to other and unspecified causes 589 Chronic kidney disease 4 B.8.2.5 236
238 588 Acute glomerulonephritis 974 Diabetes and kidney diseases 3 B.8.3 237
239 653 Skin and subcutaneous diseases 409 Non-communicable diseases 2 B.9 238
240 654 Dermatitis 653 Skin and subcutaneous diseases 3 B.9.1 239 X
241 977 Atopic dermatitis 654 Dermatitis 4 B.9.1.1 240 X
242 978 Contact dermatitis 654 Dermatitis 4 B.9.1.2 241 X
243 979 Seborrhoeic dermatitis 654 Dermatitis 4 B.9.1.3 242 X
244 655 Psoriasis 653 Skin and subcutaneous diseases 3 B.9.2 243 X
245 980 Bacterial skin diseases 653 Skin and subcutaneous diseases 3 B.9.3 244
246 656 Cellulitis 980 Bacterial skin diseases 4 B.9.3.1 245
247 657 Pyoderma 980 Bacterial skin diseases 4 B.9.3.2 246
248 658 Scabies 653 Skin and subcutaneous diseases 3 B.9.4 247 X
249 659 Fungal skin diseases 653 Skin and subcutaneous diseases 3 B.9.5 248 X
250 660 Viral skin diseases 653 Skin and subcutaneous diseases 3 B.9.6 249 X
251 661 Acne vulgaris 653 Skin and subcutaneous diseases 3 B.9.7 250 X
252 662 Alopecia areata 653 Skin and subcutaneous diseases 3 B.9.8 251 X
253 663 Pruritus 653 Skin and subcutaneous diseases 3 B.9.9 252 X
254 664 Urticaria 653 Skin and subcutaneous diseases 3 B.9.10 253 X
255 665 Decubitus ulcer 653 Skin and subcutaneous diseases 3 B.9.11 254
256 668 Other skin and subcutaneous diseases 653 Skin and subcutaneous diseases 3 B.9.12 255
257 669 Sense organ diseases 409 Non-communicable diseases 2 B.10 256 X
258 981 Blindness and vision loss 669 Sense organ diseases 3 B.10.1 257 X
259 670 Glaucoma 981 Blindness and vision loss 4 B.10.1.1 258 X
260 671 Cataract 981 Blindness and vision loss 4 B.10.1.2 259 X
261 672 Age-related macular degeneration 981 Blindness and vision loss 4 B.10.1.3 260 X
262 999 Refraction disorders 981 Blindness and vision loss 4 B.10.1.4 261 X
263 1000 Near vision loss 981 Blindness and vision loss 4 B.10.1.5 262 X
264 675 Other vision loss 981 Blindness and vision loss 4 B.10.1.6 263 X
265 674 Age-related and other hearing loss 669 Sense organ diseases 3 B.10.2 264 X
266 679 Other sense organ diseases 669 Sense organ diseases 3 B.10.3 265 X
267 626 Musculoskeletal disorders 409 Non-communicable diseases 2 B.11 266
268 627 Rheumatoid arthritis 626 Musculoskeletal disorders 3 B.11.1 267
269 628 Osteoarthritis 626 Musculoskeletal disorders 3 B.11.2 268 X
270 1014 Osteoarthritis hip 628 Osteoarthritis 4 B.11.2.1 269 X
271 1015 Osteoarthritis knee 628 Osteoarthritis 4 B.11.2.2 270 X
272 1016 Osteoarthritis hand 628 Osteoarthritis 4 B.11.2.3 271 X
273 1017 Osteoarthritis other 628 Osteoarthritis 4 B.11.2.4 272 X
274 630 Low back pain 626 Musculoskeletal disorders 3 B.11.3 273 X
275 631 Neck pain 626 Musculoskeletal disorders 3 B.11.4 274 X
276 632 Gout 626 Musculoskeletal disorders 3 B.11.5 275 X
277 639 Other musculoskeletal disorders 626 Musculoskeletal disorders 3 B.11.6 276
278 640 Other non-communicable diseases 409 Non-communicable diseases 2 B.12 277
279 641 Congenital birth defects 640 Other non-communicable diseases 3 B.12.1 278
280 642 Neural tube defects 641 Congenital birth defects 4 B.12.1.1 279
281 643 Congenital heart anomalies 641 Congenital birth defects 4 B.12.1.2 280
282 644 Orofacial clefts 641 Congenital birth defects 4 B.12.1.3 281
283 645 Down syndrome 641 Congenital birth defects 4 B.12.1.4 282
284 646 Turner syndrome 641 Congenital birth defects 4 B.12.1.5 283 X
285 647 Klinefelter syndrome 641 Congenital birth defects 4 B.12.1.6 284 X
286 648 Other chromosomal abnormalities 641 Congenital birth defects 4 B.12.1.7 285
287 649 Congenital musculoskeletal and limb anomalies 641 Congenital birth defects 4 B.12.1.8 286
288 650 Urogenital congenital anomalies 641 Congenital birth defects 4 B.12.1.9 287
289 651 Digestive congenital anomalies 641 Congenital birth defects 4 B.12.1.10 288
290 652 Other congenital birth defects 641 Congenital birth defects 4 B.12.1.11 289
291 594 Urinary diseases and male infertility 640 Other non-communicable diseases 3 B.12.2 290
292 595 Urinary tract infections and interstitial nephritis 594 Urinary diseases and male infertility 4 B.12.2.1 291
293 596 Urolithiasis 594 Urinary diseases and male infertility 4 B.12.2.2 292
294 597 Benign prostatic hyperplasia 594 Urinary diseases and male infertility 4 B.12.2.3 293 X
295 598 Male infertility 594 Urinary diseases and male infertility 4 B.12.2.4 294 X
296 602 Other urinary diseases 594 Urinary diseases and male infertility 4 B.12.2.5 295
297 603 Gynecological diseases 640 Other non-communicable diseases 3 B.12.3 296
298 604 Uterine fibroids 603 Gynecological diseases 4 B.12.3.1 297
299 605 Polycystic ovarian syndrome 603 Gynecological diseases 4 B.12.3.2 298 X
300 606 Female infertility 603 Gynecological diseases 4 B.12.3.3 299 X
301 607 Endometriosis 603 Gynecological diseases 4 B.12.3.4 300
302 608 Genital prolapse 603 Gynecological diseases 4 B.12.3.5 301
303 609 Premenstrual syndrome 603 Gynecological diseases 4 B.12.3.6 302 X
304 612 Other gynecological diseases 603 Gynecological diseases 4 B.12.3.7 303
305 613 Hemoglobinopathies and hemolytic anemias 640 Other non-communicable diseases 3 B.12.4 304
306 614 Thalassemias 613 Hemoglobinopathies and hemolytic anemias 4 B.12.4.1 305
307 837 Thalassemias trait 613 Hemoglobinopathies and hemolytic anemias 4 B.12.4.2 306 X
308 615 Sickle cell disorders 613 Hemoglobinopathies and hemolytic anemias 4 B.12.4.3 307
309 838 Sickle cell trait 613 Hemoglobinopathies and hemolytic anemias 4 B.12.4.4 308 X
310 616 G6PD deficiency 613 Hemoglobinopathies and hemolytic anemias 4 B.12.4.5 309
311 839 G6PD trait 613 Hemoglobinopathies and hemolytic anemias 4 B.12.4.6 310 X
312 618 Other hemoglobinopathies and hemolytic anemias 613 Hemoglobinopathies and hemolytic anemias 4 B.12.4.7 311
313 619 Endocrine, metabolic, blood, and immune disorders 640 Other non-communicable diseases 3 B.12.5 312
314 680 Oral disorders 640 Other non-communicable diseases 3 B.12.6 313 X
315 681 Caries of deciduous teeth 680 Oral disorders 4 B.12.6.1 314 X
316 682 Caries of permanent teeth 680 Oral disorders 4 B.12.6.2 315 X
317 683 Periodontal diseases 680 Oral disorders 4 B.12.6.3 316 X
318 684 Edentulism 680 Oral disorders 4 B.12.6.4 317 X
319 685 Other oral disorders 680 Oral disorders 4 B.12.6.5 318 X
320 686 Sudden infant death syndrome 640 Other non-communicable diseases 3 B.12.7 319 X
321 687 Injuries 294 All causes 1 C 320
322 688 Transport injuries 687 Injuries 2 C.1 321
323 689 Road injuries 688 Transport injuries 3 C.1.1 322
324 690 Pedestrian road injuries 689 Road injuries 4 C.1.1.1 323
325 691 Cyclist road injuries 689 Road injuries 4 C.1.1.2 324
326 692 Motorcyclist road injuries 689 Road injuries 4 C.1.1.3 325
327 693 Motor vehicle road injuries 689 Road injuries 4 C.1.1.4 326
328 694 Other road injuries 689 Road injuries 4 C.1.1.5 327
329 695 Other transport injuries 688 Transport injuries 3 C.1.2 328
330 696 Unintentional injuries 687 Injuries 2 C.2 329
331 697 Falls 696 Unintentional injuries 3 C.2.1 330
332 698 Drowning 696 Unintentional injuries 3 C.2.2 331
333 699 Fire, heat, and hot substances 696 Unintentional injuries 3 C.2.3 332
334 700 Poisonings 696 Unintentional injuries 3 C.2.4 333
335 701 Poisoning by carbon monoxide 700 Poisonings 4 C.2.4.1 334
336 703 Poisoning by other means 700 Poisonings 4 C.2.4.2 335
337 704 Exposure to mechanical forces 696 Unintentional injuries 3 C.2.5 336
338 705 Unintentional firearm injuries 704 Exposure to mechanical forces 4 C.2.5.1 337
339 707 Other exposure to mechanical forces 704 Exposure to mechanical forces 4 C.2.5.2 338
340 708 Adverse effects of medical treatment 696 Unintentional injuries 3 C.2.6 339
341 709 Animal contact 696 Unintentional injuries 3 C.2.7 340
342 710 Venomous animal contact 709 Animal contact 4 C.2.7.1 341
343 711 Non-venomous animal contact 709 Animal contact 4 C.2.7.2 342
344 712 Foreign body 696 Unintentional injuries 3 C.2.8 343
345 713 Pulmonary aspiration and foreign body in airway 712 Foreign body 4 C.2.8.1 344
346 714 Foreign body in eyes 712 Foreign body 4 C.2.8.2 345 X
347 715 Foreign body in other body part 712 Foreign body 4 C.2.8.3 346
348 842 Environmental heat and cold exposure 696 Unintentional injuries 3 C.2.9 347
349 729 Exposure to forces of nature 696 Unintentional injuries 3 C.2.10 348
350 716 Other unintentional injuries 696 Unintentional injuries 3 C.2.11 349
351 717 Self-harm and interpersonal violence 687 Injuries 2 C.3 350
352 718 Self-harm 717 Self-harm and interpersonal violence 3 C.3.1 351
353 721 Self-harm by firearm 718 Self-harm 4 C.3.1.1 352
354 723 Self-harm by other specified means 718 Self-harm 4 C.3.1.2 353
355 724 Interpersonal violence 717 Self-harm and interpersonal violence 3 C.3.2 354
356 725 Physical violence by firearm 724 Interpersonal violence 4 C.3.2.1 355
357 726 Physical violence by sharp object 724 Interpersonal violence 4 C.3.2.2 356
358 941 Sexual violence 724 Interpersonal violence 4 C.3.2.3 357 X
359 727 Physical violence by other means 724 Interpersonal violence 4 C.3.2.4 358
360 945 Conflict and terrorism 717 Self-harm and interpersonal violence 3 C.3.3 359
361 854 Executions and police conflict 717 Self-harm and interpersonal violence 3 C.3.4 360
362 1029 Total cancers 294 All causes 1 D 361
363 1026 Total burden related to hepatitis B 294 All causes 1 E 362
364 1027 Total burden related to hepatitis C 294 All causes 1 F 363
365 1028 Total burden related to Non-alcoholic fatty liver disease (NAFLD) 294 All causes 1 G 364

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non-db_data_sources/GBD and ICD-10_(2019 version)/GlobalBurdenDisease/Global Burden of Disease Study 2019 (GBD 2019) Cause, REI, and Location Hierarchies/IHME_GBD_2019_GBD_HIERARCHIES_INFO_SHEET_Y2022M06D29.PDF
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non-db_data_sources/GBD and ICD-10_(2019 version)/ICD10-to-GDB_expander.py
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import pandas as pd
import numpy as np
import itertools
IHME_COD_FILEPATH = "./GlobalBurdenDisease/IHME_GBD_2019_COD_CAUSE_ICD_CODE_MAP_Y2020M10D15.XLSX"
IHME_NONFATAL_FILEPATH = "./GlobalBurdenDisease/IHME_GBD_2019_NONFATAL_CAUSE_ICD_CODE_MAP_Y2020M10D15.XLSX"
ICD10CM_ORDER_FILEPATH = "./icd10_combined-who-cms.psv"
def justify(string):
'''
The purpose of this is to transform codes such as A00 and A000
into a normalized, sortable format e.g. 'A00----' and 'A000---'
'''
return string.ljust(7,"-")
class CodeRange():
def __init__(self,cause,code_book,codes):
self.cause = cause
self.code_book = code_book
self.code_list = []
codes = "" if type(codes) is float else codes #normalize codes to string...
codes = [x.strip().replace('.','').split('-') for x in codes.split(",")]
for rng in codes:
if rng[0] is None:
raise Exception("Listed ICD10 Code (Begin:{}) is not in codebook".format(rng), rng)
#lookup codes
if len(rng) == 1:
begin = justify(rng[0])
if self.code_book.get(begin) is None:
continue
else:
self.code_list.append(begin)
else:
begin = justify(rng[0])
end = justify(rng[1])
begin_bitmask = [x >= begin for x in list(self.code_book)]
end_bitmask = [x <= end for x in list(self.code_book)]
bitmask = [x and y for x,y in zip(begin_bitmask,end_bitmask)]
self.code_list.extend(list(itertools.compress(list(self.code_book),bitmask)))
def __str__(self):
txt = ''
for item in self.code_list:
txt += "{} | {}\n".format(item, self.cause)
return txt
#READ in ICD10CM codes
icd10_codes = {}
with open(ICD10CM_ORDER_FILEPATH,"r") as icd_fh:
for idx,line in enumerate(icd_fh.readlines()):
#read info
code, descr, source = line.split("|")
#cleanup info
code = justify(code.strip())
descr = descr.strip()
source = source.strip()
#Store in code dict
icd10_codes[code] = (idx,descr, source)
cod = pd.read_excel(IHME_COD_FILEPATH,header=1)
with open("COD_cause2code.psv", "w") as outfh:
itt = 0
for row in cod.itertuples():
cause = row[1]
codes = row[2]
c = CodeRange(cause,icd10_codes,codes)
outfh.write(c.__str__())
nonfatal = pd.read_excel(IHME_NONFATAL_FILEPATH,header=1)
with open("NONFATAL_cause2code.psv", "w") as outfh:
itt = 0
for row in nonfatal.itertuples():
cause = row[2]
codes= row[3]
c = CodeRange(cause,icd10_codes,codes)
outfh.write(c.__str__())

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,dad,home-pc,06.04.2023 22:41,file:///home/dad/.config/libreoffice/4;

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non-db_data_sources/GBD and ICD-10_(2019 version)/WHO ICD-10 (2019)/README.txt
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This data was obtained by opening each nested portion on the
left navigation bar at
https://icd.who.int/browse10/2019/en
and then copying and pasting the data into a text file (icd10-2019.txt).
This text file was then adjusted to get the pipe-separated values version
which
has the following columns
- code: the icd-10 code in a normalized format
- description: The basic description given
- source: This just says WHO so that it is possible to merge it with other
sources.
The adjustments were as follows (parenthases include vim search and replace
commands used):
- delete tabls (:%s/\t//g)
- delete leading spaces (:%s/^\s//)
- remove excess newlines (:%s/^\n//)
- remove periods in codes (:%s/\.//)
- Convert to Pipe-separated values file (:%s/\s/ | /)
- add column of sources (:%s/\s*$/ | WHO)
- Type in column headers

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"Level"|"Chapter"|"chapter_code"|"start_code"|"end_code"|"group_name"
1|"I Certain infectious and parasitic diseases "|1|" A00 "|" B99 "|"I Certain infectious and parasitic diseases "
2|"I Certain infectious and parasitic diseases "|1|" A00 "|" A09 "|" Intestinal infectious diseases "
2|"I Certain infectious and parasitic diseases "|1|" A15 "|" A19 "|" Tuberculosis "
2|"I Certain infectious and parasitic diseases "|1|" A20 "|" A28 "|" Certain zoonotic bacterial diseases "
2|"I Certain infectious and parasitic diseases "|1|" A30 "|" A49 "|" Other bacterial diseases "
2|"I Certain infectious and parasitic diseases "|1|" A50 "|" A64 "|" Infections with a predominantly sexual mode of transmission "
2|"I Certain infectious and parasitic diseases "|1|" A65 "|" A69 "|" Other spirochaetal diseases "
2|"I Certain infectious and parasitic diseases "|1|" A70 "|" A74 "|" Other diseases caused by chlamydiae "
2|"I Certain infectious and parasitic diseases "|1|" A75 "|" A79 "|" Rickettsioses "
2|"I Certain infectious and parasitic diseases "|1|" A80 "|" A89 "|" Viral infections of the central nervous system "
2|"I Certain infectious and parasitic diseases "|1|" A92 "|" A99 "|" Arthropod-borne viral fevers and viral haemorrhagic fevers "
2|"I Certain infectious and parasitic diseases "|1|" B00 "|" B09 "|" Viral infections characterized by skin and mucous membrane lesions "
2|"I Certain infectious and parasitic diseases "|1|" B15 "|" B19 "|" Viral hepatitis "
2|"I Certain infectious and parasitic diseases "|1|" B20 "|" B24 "|" Human immunodeficiency virus [HIV] disease "
2|"I Certain infectious and parasitic diseases "|1|" B25 "|" B34 "|" Other viral diseases "
2|"I Certain infectious and parasitic diseases "|1|" B35 "|" B49 "|" Mycoses "
2|"I Certain infectious and parasitic diseases "|1|" B50 "|" B64 "|" Protozoal diseases "
2|"I Certain infectious and parasitic diseases "|1|" B65 "|" B83 "|" Helminthiases "
2|"I Certain infectious and parasitic diseases "|1|" B85 "|" B89 "|" Pediculosis, acariasis and other infestations "
2|"I Certain infectious and parasitic diseases "|1|" B90 "|" B94 "|" Sequelae of infectious and parasitic diseases "
2|"I Certain infectious and parasitic diseases "|1|" B95 "|" B98 "|" Bacterial, viral and other infectious agents "
2|"I Certain infectious and parasitic diseases "|1|" B99 "|" B99 "|" Other infectious diseases "
1|"II Neoplasms "|2|" C00 "|" D48 "|"II Neoplasms "
2|"II Neoplasms "|2|" C00 "|" C14 "|" Malignant neoplasms of lip, oral cavity and pharynx "
2|"II Neoplasms "|2|" C15 "|" C26 "|" Malignant neoplasms of digestive organs "
2|"II Neoplasms "|2|" C30 "|" C39 "|" Malignant neoplasms of respiratory and intrathoracic organs "
2|"II Neoplasms "|2|" C40 "|" C41 "|" Malignant neoplasms of bone and articular cartilage "
2|"II Neoplasms "|2|" C43 "|" C44 "|" Melanoma and other malignant neoplasms of skin "
2|"II Neoplasms "|2|" C45 "|" C49 "|" Malignant neoplasms of mesothelial and soft tissue "
2|"II Neoplasms "|2|" C50 "|" C50 "|" Malignant neoplasm of breast "
2|"II Neoplasms "|2|" C51 "|" C58 "|" Malignant neoplasms of female genital organs "
2|"II Neoplasms "|2|" C60 "|" C63 "|" Malignant neoplasms of male genital organs "
2|"II Neoplasms "|2|" C64 "|" C68 "|" Malignant neoplasms of urinary tract "
2|"II Neoplasms "|2|" C69 "|" C72 "|" Malignant neoplasms of eye, brain and other parts of central nervous system "
2|"II Neoplasms "|2|" C73 "|" C75 "|" Malignant neoplasms of thyroid and other endocrine glands "
2|"II Neoplasms "|2|" C76 "|" C80 "|" Malignant neoplasms of ill-defined, secondary and unspecified sites "
2|"II Neoplasms "|2|" C81 "|" C96 "|" Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue "
2|"II Neoplasms "|2|" C97 "|" C97 "|" Malignant neoplasms of independent (primary) multiple sites "
2|"II Neoplasms "|2|" D00 "|" D09 "|" In situ neoplasms "
2|"II Neoplasms "|2|" D10 "|" D36 "|" Benign neoplasms "
2|"II Neoplasms "|2|" D37 "|" D48 "|" Neoplasms of uncertain or unknown behaviour "
1|"III Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism "|3|" D50 "|" D89 "|"III Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism "
2|"III Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism "|3|" D50 "|" D53 "|" Nutritional anaemias "
2|"III Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism "|3|" D55 "|" D59 "|" Haemolytic anaemias "
2|"III Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism "|3|" D60 "|" D64 "|" Aplastic and other anaemias "
2|"III Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism "|3|" D65 "|" D69 "|" Coagulation defects, purpura and other haemorrhagic conditions "
2|"III Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism "|3|" D70 "|" D77 "|" Other diseases of blood and blood-forming organs "
2|"III Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism "|3|" D80 "|" D89 "|" Certain disorders involving the immune mechanism "
1|"IV Endocrine, nutritional and metabolic diseases "|4|" E00 "|" E90 "|"IV Endocrine, nutritional and metabolic diseases "
2|"IV Endocrine, nutritional and metabolic diseases "|4|" E00 "|" E07 "|" Disorders of thyroid gland "
2|"IV Endocrine, nutritional and metabolic diseases "|4|" E10 "|" E14 "|" Diabetes mellitus "
2|"IV Endocrine, nutritional and metabolic diseases "|4|" E15 "|" E16 "|" Other disorders of glucose regulation and pancreatic internal secretion "
2|"IV Endocrine, nutritional and metabolic diseases "|4|" E20 "|" E35 "|" Disorders of other endocrine glands "
2|"IV Endocrine, nutritional and metabolic diseases "|4|" E40 "|" E46 "|" Malnutrition "
2|"IV Endocrine, nutritional and metabolic diseases "|4|" E50 "|" E64 "|" Other nutritional deficiencies "
2|"IV Endocrine, nutritional and metabolic diseases "|4|" E65 "|" E68 "|" Obesity and other hyperalimentation "
2|"IV Endocrine, nutritional and metabolic diseases "|4|" E70 "|" E90 "|" Metabolic disorders "
1|"V Mental and behavioural disorders "|5|" F00 "|" F99 "|"V Mental and behavioural disorders "
2|"V Mental and behavioural disorders "|5|" F00 "|" F09 "|" Organic, including symptomatic, mental disorders "
2|"V Mental and behavioural disorders "|5|" F10 "|" F19 "|" Mental and behavioural disorders due to psychoactive substance use "
2|"V Mental and behavioural disorders "|5|" F20 "|" F29 "|" Schizophrenia, schizotypal and delusional disorders "
2|"V Mental and behavioural disorders "|5|" F30 "|" F39 "|" Mood [affective] disorders "
2|"V Mental and behavioural disorders "|5|" F40 "|" F48 "|" Neurotic, stress-related and somatoform disorders "
2|"V Mental and behavioural disorders "|5|" F50 "|" F59 "|" Behavioural syndromes associated with physiological disturbances and physical factors "
2|"V Mental and behavioural disorders "|5|" F60 "|" F69 "|" Disorders of adult personality and behaviour "
2|"V Mental and behavioural disorders "|5|" F70 "|" F79 "|" Mental retardation "
2|"V Mental and behavioural disorders "|5|" F80 "|" F89 "|" Disorders of psychological development "
2|"V Mental and behavioural disorders "|5|" F90 "|" F98 "|" Behavioural and emotional disorders with onset usually occurring in childhood and adolescence "
2|"V Mental and behavioural disorders "|5|" F99 "|" F99 "|" Unspecified mental disorder "
1|"VI Diseases of the nervous system "|6|" G00 "|" G99 "|"VI Diseases of the nervous system "
2|"VI Diseases of the nervous system "|6|" G00 "|" G09 "|" Inflammatory diseases of the central nervous system "
2|"VI Diseases of the nervous system "|6|" G10 "|" G14 "|" Systemic atrophies primarily affecting the central nervous system "
2|"VI Diseases of the nervous system "|6|" G20 "|" G26 "|" Extrapyramidal and movement disorders "
2|"VI Diseases of the nervous system "|6|" G30 "|" G32 "|" Other degenerative diseases of the nervous system "
2|"VI Diseases of the nervous system "|6|" G35 "|" G37 "|" Demyelinating diseases of the central nervous system "
2|"VI Diseases of the nervous system "|6|" G40 "|" G47 "|" Episodic and paroxysmal disorders "
2|"VI Diseases of the nervous system "|6|" G50 "|" G59 "|" Nerve, nerve root and plexus disorders "
2|"VI Diseases of the nervous system "|6|" G60 "|" G64 "|" Polyneuropathies and other disorders of the peripheral nervous system "
2|"VI Diseases of the nervous system "|6|" G70 "|" G73 "|" Diseases of myoneural junction and muscle "
2|"VI Diseases of the nervous system "|6|" G80 "|" G83 "|" Cerebral palsy and other paralytic syndromes "
2|"VI Diseases of the nervous system "|6|" G90 "|" G99 "|" Other disorders of the nervous system "
1|"VII Diseases of the eye and adnexa "|7|" H00 "|" H59 "|"VII Diseases of the eye and adnexa "
2|"VII Diseases of the eye and adnexa "|7|" H00 "|" H06 "|" Disorders of eyelid, lacrimal system and orbit "
2|"VII Diseases of the eye and adnexa "|7|" H10 "|" H13 "|" Disorders of conjunctiva "
2|"VII Diseases of the eye and adnexa "|7|" H15 "|" H22 "|" Disorders of sclera, cornea, iris and ciliary body "
2|"VII Diseases of the eye and adnexa "|7|" H25 "|" H28 "|" Disorders of lens "
2|"VII Diseases of the eye and adnexa "|7|" H30 "|" H36 "|" Disorders of choroid and retina "
2|"VII Diseases of the eye and adnexa "|7|" H40 "|" H42 "|" Glaucoma "
2|"VII Diseases of the eye and adnexa "|7|" H43 "|" H45 "|" Disorders of vitreous body and globe "
2|"VII Diseases of the eye and adnexa "|7|" H46 "|" H48 "|" Disorders of optic nerve and visual pathways "
2|"VII Diseases of the eye and adnexa "|7|" H49 "|" H52 "|" Disorders of ocular muscles, binocular movement, accommodation and refraction "
2|"VII Diseases of the eye and adnexa "|7|" H53 "|" H54 "|" Visual disturbances and blindness "
2|"VII Diseases of the eye and adnexa "|7|" H55 "|" H59 "|" Other disorders of eye and adnexa "
1|"VIII Diseases of the ear and mastoid process "|8|" H60 "|" H95 "|"VIII Diseases of the ear and mastoid process "
2|"VIII Diseases of the ear and mastoid process "|8|" H60 "|" H62 "|" Diseases of external ear "
2|"VIII Diseases of the ear and mastoid process "|8|" H65 "|" H75 "|" Diseases of middle ear and mastoid "
2|"VIII Diseases of the ear and mastoid process "|8|" H80 "|" H83 "|" Diseases of inner ear "
2|"VIII Diseases of the ear and mastoid process "|8|" H90 "|" H95 "|" Other disorders of ear "
1|"IX Diseases of the circulatory system "|9|" I00 "|" I99 "|"IX Diseases of the circulatory system "
2|"IX Diseases of the circulatory system "|9|" I00 "|" I02 "|" Acute rheumatic fever "
2|"IX Diseases of the circulatory system "|9|" I05 "|" I09 "|" Chronic rheumatic heart diseases "
2|"IX Diseases of the circulatory system "|9|" I10 "|" I15 "|" Hypertensive diseases "
2|"IX Diseases of the circulatory system "|9|" I20 "|" I25 "|" Ischaemic heart diseases "
2|"IX Diseases of the circulatory system "|9|" I26 "|" I28 "|" Pulmonary heart disease and diseases of pulmonary circulation "
2|"IX Diseases of the circulatory system "|9|" I30 "|" I52 "|" Other forms of heart disease "
2|"IX Diseases of the circulatory system "|9|" I60 "|" I69 "|" Cerebrovascular diseases "
2|"IX Diseases of the circulatory system "|9|" I70 "|" I79 "|" Diseases of arteries, arterioles and capillaries "
2|"IX Diseases of the circulatory system "|9|" I80 "|" I89 "|" Diseases of veins, lymphatic vessels and lymph nodes, not elsewhere classified "
2|"IX Diseases of the circulatory system "|9|" I95 "|" I99 "|" Other and unspecified disorders of the circulatory system "
1|"X Diseases of the respiratory system "|10|" J00 "|" J99 "|"X Diseases of the respiratory system "
2|"X Diseases of the respiratory system "|10|" J00 "|" J06 "|" Acute upper respiratory infections "
2|"X Diseases of the respiratory system "|10|" J09 "|" J18 "|" Influenza and pneumonia "
2|"X Diseases of the respiratory system "|10|" J20 "|" J22 "|" Other acute lower respiratory infections "
2|"X Diseases of the respiratory system "|10|" J30 "|" J39 "|" Other diseases of upper respiratory tract "
2|"X Diseases of the respiratory system "|10|" J40 "|" J47 "|" Chronic lower respiratory diseases "
2|"X Diseases of the respiratory system "|10|" J60 "|" J70 "|" Lung diseases due to external agents "
2|"X Diseases of the respiratory system "|10|" J80 "|" J84 "|" Other respiratory diseases principally affecting the interstitium "
2|"X Diseases of the respiratory system "|10|" J85 "|" J86 "|" Suppurative and necrotic conditions of lower respiratory tract "
2|"X Diseases of the respiratory system "|10|" J90 "|" J94 "|" Other diseases of pleura "
2|"X Diseases of the respiratory system "|10|" J95 "|" J99 "|" Other diseases of the respiratory system "
1|"XI Diseases of the digestive system "|11|" K00 "|" K93 "|"XI Diseases of the digestive system "
2|"XI Diseases of the digestive system "|11|" K00 "|" K14 "|" Diseases of oral cavity, salivary glands and jaws "
2|"XI Diseases of the digestive system "|11|" K20 "|" K31 "|" Diseases of oesophagus, stomach and duodenum "
2|"XI Diseases of the digestive system "|11|" K35 "|" K38 "|" Diseases of appendix "
2|"XI Diseases of the digestive system "|11|" K40 "|" K46 "|" Hernia "
2|"XI Diseases of the digestive system "|11|" K50 "|" K52 "|" Noninfective enteritis and colitis "
2|"XI Diseases of the digestive system "|11|" K55 "|" K64 "|" Other diseases of intestines "
2|"XI Diseases of the digestive system "|11|" K65 "|" K67 "|" Diseases of peritoneum "
2|"XI Diseases of the digestive system "|11|" K70 "|" K77 "|" Diseases of liver "
2|"XI Diseases of the digestive system "|11|" K80 "|" K87 "|" Disorders of gallbladder, biliary tract and pancreas "
2|"XI Diseases of the digestive system "|11|" K90 "|" K93 "|" Other diseases of the digestive system "
1|"XII Diseases of the skin and subcutaneous tissue "|12|" L00 "|" L99 "|"XII Diseases of the skin and subcutaneous tissue "
2|"XII Diseases of the skin and subcutaneous tissue "|12|" L00 "|" L08 "|" Infections of the skin and subcutaneous tissue "
2|"XII Diseases of the skin and subcutaneous tissue "|12|" L10 "|" L14 "|" Bullous disorders "
2|"XII Diseases of the skin and subcutaneous tissue "|12|" L20 "|" L30 "|" Dermatitis and eczema "
2|"XII Diseases of the skin and subcutaneous tissue "|12|" L40 "|" L45 "|" Papulosquamous disorders "
2|"XII Diseases of the skin and subcutaneous tissue "|12|" L50 "|" L54 "|" Urticaria and erythema "
2|"XII Diseases of the skin and subcutaneous tissue "|12|" L55 "|" L59 "|" Radiation-related disorders of the skin and subcutaneous tissue "
2|"XII Diseases of the skin and subcutaneous tissue "|12|" L60 "|" L75 "|" Disorders of skin appendages "
2|"XII Diseases of the skin and subcutaneous tissue "|12|" L80 "|" L99 "|" Other disorders of the skin and subcutaneous tissue "
1|"XIII Diseases of the musculoskeletal system and connective tissue "|13|" M00 "|" M99 "|"XIII Diseases of the musculoskeletal system and connective tissue "
2|"XIII Diseases of the musculoskeletal system and connective tissue "|13|" M00 "|" M25 "|" Arthropathies "
2|"XIII Diseases of the musculoskeletal system and connective tissue "|13|" M30 "|" M36 "|" Systemic connective tissue disorders "
2|"XIII Diseases of the musculoskeletal system and connective tissue "|13|" M40 "|" M54 "|" Dorsopathies "
2|"XIII Diseases of the musculoskeletal system and connective tissue "|13|" M60 "|" M79 "|" Soft tissue disorders "
2|"XIII Diseases of the musculoskeletal system and connective tissue "|13|" M80 "|" M94 "|" Osteopathies and chondropathies "
2|"XIII Diseases of the musculoskeletal system and connective tissue "|13|" M95 "|" M99 "|" Other disorders of the musculoskeletal system and connective tissue "
1|"XIV Diseases of the genitourinary system "|14|" N00 "|" N99 "|"XIV Diseases of the genitourinary system "
2|"XIV Diseases of the genitourinary system "|14|" N00 "|" N08 "|" Glomerular diseases "
2|"XIV Diseases of the genitourinary system "|14|" N10 "|" N16 "|" Renal tubulo-interstitial diseases "
2|"XIV Diseases of the genitourinary system "|14|" N17 "|" N19 "|" Renal failure "
2|"XIV Diseases of the genitourinary system "|14|" N20 "|" N23 "|" Urolithiasis "
2|"XIV Diseases of the genitourinary system "|14|" N25 "|" N29 "|" Other disorders of kidney and ureter "
2|"XIV Diseases of the genitourinary system "|14|" N30 "|" N39 "|" Other diseases of urinary system "
2|"XIV Diseases of the genitourinary system "|14|" N40 "|" N51 "|" Diseases of male genital organs "
2|"XIV Diseases of the genitourinary system "|14|" N60 "|" N64 "|" Disorders of breast "
2|"XIV Diseases of the genitourinary system "|14|" N70 "|" N77 "|" Inflammatory diseases of female pelvic organs "
2|"XIV Diseases of the genitourinary system "|14|" N80 "|" N98 "|" Noninflammatory disorders of female genital tract "
2|"XIV Diseases of the genitourinary system "|14|" N99 "|" N99 "|" Other disorders of the genitourinary system "
1|"XV Pregnancy, childbirth and the puerperium "|15|" O00 "|" O99 "|"XV Pregnancy, childbirth and the puerperium "
2|"XV Pregnancy, childbirth and the puerperium "|15|" O00 "|" O08 "|" Pregnancy with abortive outcome "
2|"XV Pregnancy, childbirth and the puerperium "|15|" O10 "|" O16 "|" Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium "
2|"XV Pregnancy, childbirth and the puerperium "|15|" O20 "|" O29 "|" Other maternal disorders predominantly related to pregnancy "
2|"XV Pregnancy, childbirth and the puerperium "|15|" O30 "|" O48 "|" Maternal care related to the fetus and amniotic cavity and possible delivery problems "
2|"XV Pregnancy, childbirth and the puerperium "|15|" O60 "|" O75 "|" Complications of labour and delivery "
2|"XV Pregnancy, childbirth and the puerperium "|15|" O80 "|" O84 "|" Delivery "
2|"XV Pregnancy, childbirth and the puerperium "|15|" O85 "|" O92 "|" Complications predominantly related to the puerperium "
2|"XV Pregnancy, childbirth and the puerperium "|15|" O94 "|" O99 "|" Other obstetric conditions, not elsewhere classified "
1|"XVI Certain conditions originating in the perinatal period "|16|" P00 "|" P96 "|"XVI Certain conditions originating in the perinatal period "
2|"XVI Certain conditions originating in the perinatal period "|16|" P00 "|" P04 "|" Fetus and newborn affected by maternal factors and by complications of pregnancy, labour and delivery "
2|"XVI Certain conditions originating in the perinatal period "|16|" P05 "|" P08 "|" Disorders related to length of gestation and fetal growth "
2|"XVI Certain conditions originating in the perinatal period "|16|" P10 "|" P15 "|" Birth trauma "
2|"XVI Certain conditions originating in the perinatal period "|16|" P20 "|" P29 "|" Respiratory and cardiovascular disorders specific to the perinatal period "
2|"XVI Certain conditions originating in the perinatal period "|16|" P35 "|" P39 "|" Infections specific to the perinatal period "
2|"XVI Certain conditions originating in the perinatal period "|16|" P50 "|" P61 "|" Haemorrhagic and haematological disorders of fetus and newborn "
2|"XVI Certain conditions originating in the perinatal period "|16|" P70 "|" P74 "|" Transitory endocrine and metabolic disorders specific to fetus and newborn "
2|"XVI Certain conditions originating in the perinatal period "|16|" P75 "|" P78 "|" Digestive system disorders of fetus and newborn "
2|"XVI Certain conditions originating in the perinatal period "|16|" P80 "|" P83 "|" Conditions involving the integument and temperature regulation of fetus and newborn "
2|"XVI Certain conditions originating in the perinatal period "|16|" P90 "|" P96 "|" Other disorders originating in the perinatal period "
1|"XVII Congenital malformations, deformations and chromosomal abnormalities "|17|" Q00 "|" Q99 "|"XVII Congenital malformations, deformations and chromosomal abnormalities "
2|"XVII Congenital malformations, deformations and chromosomal abnormalities "|17|" Q00 "|" Q07 "|" Congenital malformations of the nervous system "
2|"XVII Congenital malformations, deformations and chromosomal abnormalities "|17|" Q10 "|" Q18 "|" Congenital malformations of eye, ear, face and neck "
2|"XVII Congenital malformations, deformations and chromosomal abnormalities "|17|" Q20 "|" Q28 "|" Congenital malformations of the circulatory system "
2|"XVII Congenital malformations, deformations and chromosomal abnormalities "|17|" Q30 "|" Q34 "|" Congenital malformations of the respiratory system "
2|"XVII Congenital malformations, deformations and chromosomal abnormalities "|17|" Q35 "|" Q37 "|" Cleft lip and cleft palate "
2|"XVII Congenital malformations, deformations and chromosomal abnormalities "|17|" Q38 "|" Q45 "|" Other congenital malformations of the digestive system "
2|"XVII Congenital malformations, deformations and chromosomal abnormalities "|17|" Q50 "|" Q56 "|" Congenital malformations of genital organs "
2|"XVII Congenital malformations, deformations and chromosomal abnormalities "|17|" Q60 "|" Q64 "|" Congenital malformations of the urinary system "
2|"XVII Congenital malformations, deformations and chromosomal abnormalities "|17|" Q65 "|" Q79 "|" Congenital malformations and deformations of the musculoskeletal system "
2|"XVII Congenital malformations, deformations and chromosomal abnormalities "|17|" Q80 "|" Q89 "|" Other congenital malformations "
2|"XVII Congenital malformations, deformations and chromosomal abnormalities "|17|" Q90 "|" Q99 "|" Chromosomal abnormalities, not elsewhere classified "
1|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "|18|" R00 "|" R99 "|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "
2|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "|18|" R00 "|" R09 "|" Symptoms and signs involving the circulatory and respiratory systems "
2|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "|18|" R10 "|" R19 "|" Symptoms and signs involving the digestive system and abdomen "
2|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "|18|" R20 "|" R23 "|" Symptoms and signs involving the skin and subcutaneous tissue "
2|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "|18|" R25 "|" R29 "|" Symptoms and signs involving the nervous and musculoskeletal systems "
2|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "|18|" R30 "|" R39 "|" Symptoms and signs involving the urinary system "
2|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "|18|" R40 "|" R46 "|" Symptoms and signs involving cognition, perception, emotional state and behaviour "
2|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "|18|" R47 "|" R49 "|" Symptoms and signs involving speech and voice "
2|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "|18|" R50 "|" R69 "|" General symptoms and signs "
2|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "|18|" R70 "|" R79 "|" Abnormal findings on examination of blood, without diagnosis "
2|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "|18|" R80 "|" R82 "|" Abnormal findings on examination of urine, without diagnosis "
2|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "|18|" R83 "|" R89 "|" Abnormal findings on examination of other body fluids, substances and tissues, without diagnosis "
2|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "|18|" R90 "|" R94 "|" Abnormal findings on diagnostic imaging and in function studies, without diagnosis "
2|"XVIII Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified "|18|" R95 "|" R99 "|" Ill-defined and unknown causes of mortality "
1|"XIX Injury, poisoning and certain other consequences of external causes "|19|" S00 "|" T98 "|"XIX Injury, poisoning and certain other consequences of external causes "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" S00 "|" S09 "|" Injuries to the head "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" S10 "|" S19 "|" Injuries to the neck "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" S20 "|" S29 "|" Injuries to the thorax "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" S30 "|" S39 "|" Injuries to the abdomen, lower back, lumbar spine and pelvis "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" S40 "|" S49 "|" Injuries to the shoulder and upper arm "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" S50 "|" S59 "|" Injuries to the elbow and forearm "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" S60 "|" S69 "|" Injuries to the wrist and hand "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" S70 "|" S79 "|" Injuries to the hip and thigh "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" S80 "|" S89 "|" Injuries to the knee and lower leg "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" S90 "|" S99 "|" Injuries to the ankle and foot "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" T00 "|" T07 "|" Injuries involving multiple body regions "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" T08 "|" T14 "|" Injuries to unspecified part of trunk, limb or body region "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" T15 "|" T19 "|" Effects of foreign body entering through natural orifice "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" T20 "|" T32 "|" Burns and corrosions "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" T33 "|" T35 "|" Frostbite "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" T36 "|" T50 "|" Poisoning by drugs, medicaments and biological substances "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" T51 "|" T65 "|" Toxic effects of substances chiefly nonmedicinal as to source "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" T66 "|" T78 "|" Other and unspecified effects of external causes "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" T79 "|" T79 "|" Certain early complications of trauma "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" T80 "|" T88 "|" Complications of surgical and medical care, not elsewhere classified "
2|"XIX Injury, poisoning and certain other consequences of external causes "|19|" T90 "|" T98 "|" Sequelae of injuries, of poisoning and of other consequences of external causes "
1|"XX External causes of morbidity and mortality "|20|" V01 "|" Y98 "|"XX External causes of morbidity and mortality "
2|"XX External causes of morbidity and mortality "|20|" V01 "|" X59 "|" Accidents "
2|"XX External causes of morbidity and mortality "|20|" X60 "|" X84 "|" Intentional self-harm "
2|"XX External causes of morbidity and mortality "|20|" X85 "|" Y09 "|" Assault "
2|"XX External causes of morbidity and mortality "|20|" Y10 "|" Y34 "|" Event of undetermined intent "
2|"XX External causes of morbidity and mortality "|20|" Y35 "|" Y36 "|" Legal intervention and operations of war "
2|"XX External causes of morbidity and mortality "|20|" Y40 "|" Y84 "|" Complications of medical and surgical care "
2|"XX External causes of morbidity and mortality "|20|" Y85 "|" Y89 "|" Sequelae of external causes of morbidity and mortality "
2|"XX External causes of morbidity and mortality "|20|" Y90 "|" Y98 "|" Supplementary factors related to causes of morbidity and mortality classified elsewhere "
1|"XXI Factors influencing health status and contact with health services "|21|" Z00 "|" Z99 "|"XXI Factors influencing health status and contact with health services "
2|"XXI Factors influencing health status and contact with health services "|21|" Z00 "|" Z13 "|" Persons encountering health services for examination and investigation "
2|"XXI Factors influencing health status and contact with health services "|21|" Z20 "|" Z29 "|" Persons with potential health hazards related to communicable diseases "
2|"XXI Factors influencing health status and contact with health services "|21|" Z30 "|" Z39 "|" Persons encountering health services in circumstances related to reproduction "
2|"XXI Factors influencing health status and contact with health services "|21|" Z40 "|" Z54 "|" Persons encountering health services for specific procedures and health care "
2|"XXI Factors influencing health status and contact with health services "|21|" Z55 "|" Z65 "|" Persons with potential health hazards related to socioeconomic and psychosocial circumstances "
2|"XXI Factors influencing health status and contact with health services "|21|" Z70 "|" Z76 "|" Persons encountering health services in other circumstances "
2|"XXI Factors influencing health status and contact with health services "|21|" Z80 "|" Z99 "|" Persons with potential health hazards related to family and personal history and certain conditions influencing health status "
1|"XXII Codes for special purposes "|22|" U00 "|" U85 "|"XXII Codes for special purposes "
2|"XXII Codes for special purposes "|22|" U00 "|" U49 "|" Provisional assignment of new diseases of uncertain etiology or emergency use "
2|"XXII Codes for special purposes "|22|" U82 "|" U85 "|" Resistance to antimicrobial and antineoplastic drugs "

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non-db_data_sources/GBD and ICD-10_(2019 version)/WHO ICD-10 (2019)/icd10_categories.txt
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A00 | A09 | Intestinal infectious diseases
A15 | A19 | Tuberculosis
A20 | A28 | Certain zoonotic bacterial diseases
A30 | A49 | Other bacterial diseases
A50 | A64 | Infections with a predominantly sexual mode of transmission
A65 | A69 | Other spirochaetal diseases
A70 | A74 | Other diseases caused by chlamydiae
A75 | A79 | Rickettsioses
A80 | A89 | Viral infections of the central nervous system
A92 | A99 | Arthropod-borne viral fevers and viral haemorrhagic fevers
B00 | B09 | Viral infections characterized by skin and mucous membrane lesions
B15 | B19 | Viral hepatitis
B20 | B24 | Human immunodeficiency virus [HIV] disease
B25 | B34 | Other viral diseases
B35 | B49 | Mycoses
B50 | B64 | Protozoal diseases
B65 | B83 | Helminthiases
B85 | B89 | Pediculosis, acariasis and other infestations
B90 | B94 | Sequelae of infectious and parasitic diseases
B95 | B98 | Bacterial, viral and other infectious agents
B99 | B99 | Other infectious diseases
C00 | C14 | Malignant neoplasms of lip, oral cavity and pharynx
C15 | C26 | Malignant neoplasms of digestive organs
C30 | C39 | Malignant neoplasms of respiratory and intrathoracic organs
C40 | C41 | Malignant neoplasms of bone and articular cartilage
C43 | C44 | Melanoma and other malignant neoplasms of skin
C45 | C49 | Malignant neoplasms of mesothelial and soft tissue
C50 | C50 | Malignant neoplasm of breast
C51 | C58 | Malignant neoplasms of female genital organs
C60 | C63 | Malignant neoplasms of male genital organs
C64 | C68 | Malignant neoplasms of urinary tract
C69 | C72 | Malignant neoplasms of eye, brain and other parts of central nervous system
C73 | C75 | Malignant neoplasms of thyroid and other endocrine glands
C76 | C80 | Malignant neoplasms of ill-defined, secondary and unspecified sites
C81 | C96 | Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
C97 | C97 | Malignant neoplasms of independent (primary) multiple sites
D00 | D09 | In situ neoplasms
D10 | D36 | Benign neoplasms
D37 | D48 | Neoplasms of uncertain or unknown behaviour
D50 | D53 | Nutritional anaemias
D55 | D59 | Haemolytic anaemias
D60 | D64 | Aplastic and other anaemias
D65 | D69 | Coagulation defects, purpura and other haemorrhagic conditions
D70 | D77 | Other diseases of blood and blood-forming organs
D80 | D89 | Certain disorders involving the immune mechanism
E00 | E07 | Disorders of thyroid gland
E10 | E14 | Diabetes mellitus
E15 | E16 | Other disorders of glucose regulation and pancreatic internal secretion
E20 | E35 | Disorders of other endocrine glands
E40 | E46 | Malnutrition
E50 | E64 | Other nutritional deficiencies
E65 | E68 | Obesity and other hyperalimentation
E70 | E90 | Metabolic disorders
F00 | F09 | Organic, including symptomatic, mental disorders
F10 | F19 | Mental and behavioural disorders due to psychoactive substance use
F20 | F29 | Schizophrenia, schizotypal and delusional disorders
F30 | F39 | Mood [affective] disorders
F40 | F48 | Neurotic, stress-related and somatoform disorders
F50 | F59 | Behavioural syndromes associated with physiological disturbances and physical factors
F60 | F69 | Disorders of adult personality and behaviour
F70 | F79 | Mental retardation
F80 | F89 | Disorders of psychological development
F90 | F98 | Behavioural and emotional disorders with onset usually occurring in childhood and adolescence
F99 | F99 | Unspecified mental disorder
G00 | G09 | Inflammatory diseases of the central nervous system
G10 | G14 | Systemic atrophies primarily affecting the central nervous system
G20 | G26 | Extrapyramidal and movement disorders
G30 | G32 | Other degenerative diseases of the nervous system
G35 | G37 | Demyelinating diseases of the central nervous system
G40 | G47 | Episodic and paroxysmal disorders
G50 | G59 | Nerve, nerve root and plexus disorders
G60 | G64 | Polyneuropathies and other disorders of the peripheral nervous system
G70 | G73 | Diseases of myoneural junction and muscle
G80 | G83 | Cerebral palsy and other paralytic syndromes
G90 | G99 | Other disorders of the nervous system
H00 | H06 | Disorders of eyelid, lacrimal system and orbit
H10 | H13 | Disorders of conjunctiva
H15 | H22 | Disorders of sclera, cornea, iris and ciliary body
H25 | H28 | Disorders of lens
H30 | H36 | Disorders of choroid and retina
H40 | H42 | Glaucoma
H43 | H45 | Disorders of vitreous body and globe
H46 | H48 | Disorders of optic nerve and visual pathways
H49 | H52 | Disorders of ocular muscles, binocular movement, accommodation and refraction
H53 | H54 | Visual disturbances and blindness
H55 | H59 | Other disorders of eye and adnexa
H60 | H62 | Diseases of external ear
H65 | H75 | Diseases of middle ear and mastoid
H80 | H83 | Diseases of inner ear
H90 | H95 | Other disorders of ear
I00 | I02 | Acute rheumatic fever
I05 | I09 | Chronic rheumatic heart diseases
I10 | I15 | Hypertensive diseases
I20 | I25 | Ischaemic heart diseases
I26 | I28 | Pulmonary heart disease and diseases of pulmonary circulation
I30 | I52 | Other forms of heart disease
I60 | I69 | Cerebrovascular diseases
I70 | I79 | Diseases of arteries, arterioles and capillaries
I80 | I89 | Diseases of veins, lymphatic vessels and lymph nodes, not elsewhere classified
I95 | I99 | Other and unspecified disorders of the circulatory system
J00 | J06 | Acute upper respiratory infections
J09 | J18 | Influenza and pneumonia
J20 | J22 | Other acute lower respiratory infections
J30 | J39 | Other diseases of upper respiratory tract
J40 | J47 | Chronic lower respiratory diseases
J60 | J70 | Lung diseases due to external agents
J80 | J84 | Other respiratory diseases principally affecting the interstitium
J85 | J86 | Suppurative and necrotic conditions of lower respiratory tract
J90 | J94 | Other diseases of pleura
J95 | J99 | Other diseases of the respiratory system
K00 | K14 | Diseases of oral cavity, salivary glands and jaws
K20 | K31 | Diseases of oesophagus, stomach and duodenum
K35 | K38 | Diseases of appendix
K40 | K46 | Hernia
K50 | K52 | Noninfective enteritis and colitis
K55 | K64 | Other diseases of intestines
K65 | K67 | Diseases of peritoneum
K70 | K77 | Diseases of liver
K80 | K87 | Disorders of gallbladder, biliary tract and pancreas
K90 | K93 | Other diseases of the digestive system
L00 | L08 | Infections of the skin and subcutaneous tissue
L10 | L14 | Bullous disorders
L20 | L30 | Dermatitis and eczema
L40 | L45 | Papulosquamous disorders
L50 | L54 | Urticaria and erythema
L55 | L59 | Radiation-related disorders of the skin and subcutaneous tissue
L60 | L75 | Disorders of skin appendages
L80 | L99 | Other disorders of the skin and subcutaneous tissue
M00 | M25 | Arthropathies
M30 | M36 | Systemic connective tissue disorders
M40 | M54 | Dorsopathies
M60 | M79 | Soft tissue disorders
M80 | M94 | Osteopathies and chondropathies
M95 | M99 | Other disorders of the musculoskeletal system and connective tissue
N00 | N08 | Glomerular diseases
N10 | N16 | Renal tubulo-interstitial diseases
N17 | N19 | Renal failure
N20 | N23 | Urolithiasis
N25 | N29 | Other disorders of kidney and ureter
N30 | N39 | Other diseases of urinary system
N40 | N51 | Diseases of male genital organs
N60 | N64 | Disorders of breast
N70 | N77 | Inflammatory diseases of female pelvic organs
N80 | N98 | Noninflammatory disorders of female genital tract
N99 | N99 | Other disorders of the genitourinary system
O00 | O08 | Pregnancy with abortive outcome
O10 | O16 | Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium
O20 | O29 | Other maternal disorders predominantly related to pregnancy
O30 | O48 | Maternal care related to the fetus and amniotic cavity and possible delivery problems
O60 | O75 | Complications of labour and delivery
O80 | O84 | Delivery
O85 | O92 | Complications predominantly related to the puerperium
O94 | O99 | Other obstetric conditions, not elsewhere classified
P00 | P04 | Fetus and newborn affected by maternal factors and by complications of pregnancy, labour and delivery
P05 | P08 | Disorders related to length of gestation and fetal growth
P10 | P15 | Birth trauma
P20 | P29 | Respiratory and cardiovascular disorders specific to the perinatal period
P35 | P39 | Infections specific to the perinatal period
P50 | P61 | Haemorrhagic and haematological disorders of fetus and newborn
P70 | P74 | Transitory endocrine and metabolic disorders specific to fetus and newborn
P75 | P78 | Digestive system disorders of fetus and newborn
P80 | P83 | Conditions involving the integument and temperature regulation of fetus and newborn
P90 | P96 | Other disorders originating in the perinatal period
Q00 | Q07 | Congenital malformations of the nervous system
Q10 | Q18 | Congenital malformations of eye, ear, face and neck
Q20 | Q28 | Congenital malformations of the circulatory system
Q30 | Q34 | Congenital malformations of the respiratory system
Q35 | Q37 | Cleft lip and cleft palate
Q38 | Q45 | Other congenital malformations of the digestive system
Q50 | Q56 | Congenital malformations of genital organs
Q60 | Q64 | Congenital malformations of the urinary system
Q65 | Q79 | Congenital malformations and deformations of the musculoskeletal system
Q80 | Q89 | Other congenital malformations
Q90 | Q99 | Chromosomal abnormalities, not elsewhere classified
R00 | R09 | Symptoms and signs involving the circulatory and respiratory systems
R10 | R19 | Symptoms and signs involving the digestive system and abdomen
R20 | R23 | Symptoms and signs involving the skin and subcutaneous tissue
R25 | R29 | Symptoms and signs involving the nervous and musculoskeletal systems
R30 | R39 | Symptoms and signs involving the urinary system
R40 | R46 | Symptoms and signs involving cognition, perception, emotional state and behaviour
R47 | R49 | Symptoms and signs involving speech and voice
R50 | R69 | General symptoms and signs
R70 | R79 | Abnormal findings on examination of blood, without diagnosis
R80 | R82 | Abnormal findings on examination of urine, without diagnosis
R83 | R89 | Abnormal findings on examination of other body fluids, substances and tissues, without diagnosis
R90 | R94 | Abnormal findings on diagnostic imaging and in function studies, without diagnosis
R95 | R99 | Ill-defined and unknown causes of mortality
S00 | S09 | Injuries to the head
S10 | S19 | Injuries to the neck
S20 | S29 | Injuries to the thorax
S30 | S39 | Injuries to the abdomen, lower back, lumbar spine and pelvis
S40 | S49 | Injuries to the shoulder and upper arm
S50 | S59 | Injuries to the elbow and forearm
S60 | S69 | Injuries to the wrist and hand
S70 | S79 | Injuries to the hip and thigh
S80 | S89 | Injuries to the knee and lower leg
S90 | S99 | Injuries to the ankle and foot
T00 | T07 | Injuries involving multiple body regions
T08 | T14 | Injuries to unspecified part of trunk, limb or body region
T15 | T19 | Effects of foreign body entering through natural orifice
T20 | T32 | Burns and corrosions
T33 | T35 | Frostbite
T36 | T50 | Poisoning by drugs, medicaments and biological substances
T51 | T65 | Toxic effects of substances chiefly nonmedicinal as to source
T66 | T78 | Other and unspecified effects of external causes
T79 | T79 | Certain early complications of trauma
T80 | T88 | Complications of surgical and medical care, not elsewhere classified
T90 | T98 | Sequelae of injuries, of poisoning and of other consequences of external causes
V01 | X59 | Accidents
X60 | X84 | Intentional self-harm
X85 | Y09 | Assault
Y10 | Y34 | Event of undetermined intent
Y35 | Y36 | Legal intervention and operations of war
Y40 | Y84 | Complications of medical and surgical care
Y85 | Y89 | Sequelae of external causes of morbidity and mortality
Y90 | Y98 | Supplementary factors related to causes of morbidity and mortality classified elsewhere
Z00 | Z13 | Persons encountering health services for examination and investigation
Z20 | Z29 | Persons with potential health hazards related to communicable diseases
Z30 | Z39 | Persons encountering health services in circumstances related to reproduction
Z40 | Z54 | Persons encountering health services for specific procedures and health care
Z55 | Z65 | Persons with potential health hazards related to socioeconomic and psychosocial circumstances
Z70 | Z76 | Persons encountering health services in other circumstances
Z80 | Z99 | Persons with potential health hazards related to family and personal history and certain conditions influencing health status
U00 | U49 | Provisional assignment of new diseases of uncertain etiology or emergency use
U82 | U85 | Resistance to antimicrobial and antineoplastic drugs

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This contains the CMS version of ICD-10-CM codes.
I have included a version I converted to pip-separated values with the
following columns
- code : the IDC-10-cm code.
- description: a basic description
- source: Says CMS-cm so that it can be combined with other sources.

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non-db_data_sources/GBD and ICD-10_(2019 version)/merge_icd-versions.sh
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#!/bin/bash
icd10_who="./WHO ICD-10 (2019)/icd10-2019_categories_only.psv"
icd10cm_cms="./icd10cm_codes_addenda_2019/icd10cm_codes_2019.psv"
#concatenate the two files
#then lexically sort them by first column and then second column(reversed)
#then sort/unique based on first column
#then save to file
cat "$icd10_who" "$icd10cm_cms" | sort -t "|" -k 1,1 -k 3,3r | sort -u -t "|" -k 1,1 > icd10_combined-who-cms.psv

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USP[[:space:]]DC/USP_DC_12_2021_RELEASE_1.0.xlsx filter=lfs diff=lfs merge=lfs -text
USP[[:space:]]DC/usp_dc_pub_2023_release_2.0_updated_final.xlsx filter=lfs diff=lfs merge=lfs -text
USP[[:space:]]MMG/Final_Report_and_Summary_of_Methodology_and_Approach_v1.1.pdf filter=lfs diff=lfs merge=lfs -text
USP[[:space:]]MMG/MMG_v8.0_Alignment_File.xlsx filter=lfs diff=lfs merge=lfs -text
USP[[:space:]]MMG/Summary_of_Changes_between_MMGv7.0_and_MMGv8.0.pdf filter=lfs diff=lfs merge=lfs -text
USP[[:space:]]MMG/USP_Medicare_Model_Guidelines_v8.0__All_Excel_Spreadsheets_.xlsx filter=lfs diff=lfs merge=lfs -text
USP[[:space:]]MMG/USP_Medicare_Model_Guidelines_v8.0__Categories_and_Classes_.pdf filter=lfs diff=lfs merge=lfs -text
USP[[:space:]]MMG/USP_Medicare_Model_Guidelines_v8.0__Showing_changes_from_v7.0_.pdf filter=lfs diff=lfs merge=lfs -text
USP[[:space:]]MMG/USP_Medicare_Model_Guidelines_v8.0__With_Example_Part_D_Drugs_.pdf filter=lfs diff=lfs merge=lfs -text

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GBD Results tool:
Use the following to cite data included in this download:
Global Burden of Disease Collaborative Network.
Global Burden of Disease Study 2019 (GBD 2019) Results.
Seattle, United States: Institute for Health Metrics and Evaluation (IHME), 2020.
Available from https://vizhub.healthdata.org/gbd-results/.

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I imported this data using Dbeaver's import function.
I specifically used the IHME-GBD_2019_DATA-IMPORT.csv
version because I adjusted things so they imported easily.

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