NCT02443324 · STUDY IN CONTEXT

A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

DLT is defined as an Adverse Event (AE) that is likely related to study medication or combination,and fulfills any one of following criteria:Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade (Gr) 3 and 4 nonlaboratory toxicity (tox),Any Gr 3 or 4 laboratory value if medical intervention is required to treat participant (pt) or abnormality persists for \>1 week;Hematologic tox:Gr 4 toxicity lasting ≥ 7 days,or Gr 3 thrombocytopenia if associated with bleeding and requires platelet transfusion,or Febrile neutropenia Gr 3 or Gr 4;GR 5 tox (death);Any toxicity that is possibly related to study treatment that requires withdrawal of pt from study during Cycle 1,A delay of \> 14 days due to persistent Grade ≥ 2 toxicities in initiating Cycle 2,with exception of Grade 2 fatigue;Any infusion or hypersensitivity reactions are NOT a DLT. A summary of other nonserious AEs and all Serious AEs,regardless of causality is located in Reported Adverse Event section.

All enrolled participants who received at least one dose of the study drug in dose escalation phase and experienced a DLT. DLT was assessed in Phase 1a of Cohorts A and C during Cycle 1.

→

secondary · POSTED

Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.

All enrolled participants who received at least one dose of the study drug. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B).

→

secondary · POSTED

Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. Participants who do not have any postbaseline tumor response assessments for any reason were considered.

→

secondary · POSTED

The duration of response is defined only for responders (patients with a confirmed CR or PR). It is measured from the date of first evidence of a confirmed CR or PR to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, DoR will be censored at the date of the last complete objective progression-free disease assessment (CR or PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.

→

secondary · POSTED

TTR is defined as the time from the date of first study treatment until the first evidence of a confirmed CR or PR.

→

secondary · POSTED

PFS is defined as the time from the date of first study treatment until the date of the first observed radiographically documented progressive disease (PD) or death due to any cause, whichever is earlier. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.

All enrolled participants who received at least one dose of the study drug. Censored participants: Cohort A and B = 3; Cohort A1 = 4; Cohort A2 = 8; Cohort C = 10; Cohort D = 3 and Cohort E = 13. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B).

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-gastroesophageal-junction-carcinoma
nct id: NCT02443324
trial label: A Study of Ramucirumab Plus Pembrolizumab in Participants With Gastric or GEJ Adenocarcinoma, NSCLC, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 7
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0000
source section id
NCT02443324-om-0000
source outcome index
0
endpoint
Phase 1a: Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
endpoint definition
DLT is defined as an Adverse Event (AE) that is likely related to study medication or combination,and fulfills any one of following criteria:Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade (Gr) 3 and 4 nonlaboratory toxicity (tox),Any Gr 3 or 4 laboratory value if medical intervention is required to treat participant (pt) or abnormality persists for \>1 week;Hematologic tox:Gr 4 toxicity lasting ≥ 7 days,or Gr 3 thrombocytopenia if associated with bleeding and requires platelet transfusion,or Febrile neutropenia Gr 3 or Gr 4;GR 5 tox (death);Any toxicity that is possibly related to study treatment that requires withdrawal of pt from study during Cycle 1,A delay of \> 14 days due to persistent Grade ≥ 2 toxicities in initiating Cycle 2,with exception of Grade 2 fatigue;Any infusion or hypersensitivity reactions are NOT a DLT. A summary of other nonserious AEs and all Serious AEs,regardless of causality is located in Reported Adverse Event section.
time origin
Cycle 1 (21 Days)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All enrolled participants who received at least one dose of the study drug in dose escalation phase and experienced a DLT. DLT was assessed in Phase 1a of Cohorts A and C during Cycle 1.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0001
source section id
NCT02443324-om-0001
source outcome index
1
endpoint
Phase 1a and 1b: Percentage of Participants Who Achieve Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
endpoint definition
Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants per cohort with at least 1 measurable lesion, multiplied by 100. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
time origin
Baseline to Measured Progressive Disease (Up to 24 Months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All enrolled participants who received at least one dose of the study drug. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0002
source section id
NCT02443324-om-0002
source outcome index
2
endpoint
Phase 1a and 1b: Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]
endpoint definition
Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. Participants who do not have any postbaseline tumor response assessments for any reason were considered.
time origin
Baseline to Measured Progressive Disease (Up to 24 Months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All enrolled participants who received at least one dose of the study drug. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0003
source section id
NCT02443324-om-0003
source outcome index
3
endpoint
Phase 1a and 1b: Duration of Response (DoR)
endpoint definition
The duration of response is defined only for responders (patients with a confirmed CR or PR). It is measured from the date of first evidence of a confirmed CR or PR to the date of objective progression or the date of death due to any cause, whichever is earlier. If a responder is not known to have died or have objective progression as of the data inclusion cutoff date, DoR will be censored at the date of the last complete objective progression-free disease assessment (CR or PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
time origin
Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 24 Months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All enrolled participants who received at least one dose of the study drug. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0004
source section id
NCT02443324-om-0004
source outcome index
4
endpoint
Phase 1a and 1b: Time to First Response (TTR)
endpoint definition
TTR is defined as the time from the date of first study treatment until the first evidence of a confirmed CR or PR.
time origin
Baseline to Date of CR or PR (Up to 24 Months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All enrolled participants who received at least one dose of the study drug. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0005
source section id
NCT02443324-om-0005
source outcome index
5
endpoint
Phase 1a and 1b: Progression Free Survival (PFS)
endpoint definition
PFS is defined as the time from the date of first study treatment until the date of the first observed radiographically documented progressive disease (PD) or death due to any cause, whichever is earlier. PD was determined using RECIST criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
time origin
Baseline to PD or Death of Any Cause (Up to 24 Months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All enrolled participants who received at least one dose of the study drug. Censored participants: Cohort A and B = 3; Cohort A1 = 4; Cohort A2 = 8; Cohort C = 10; Cohort D = 3 and Cohort E = 13. Per Protocol, Cohort A and B participants \[Gastric-GEJ cancer (Second-Third L)\] were combined and outcome data was analyzed under a single arm (Cohort A and B).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0000
arm key
OG000
arm label
Cohort A
regimen
Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02443324-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0000
arm key
OG001
arm label
Cohort C
regimen
Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02443324-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0001
arm key
OG000
arm label
Cohort A and B
regimen
Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle in Cohort A. Participants with Gastric-GEJ cancer (Second-Third L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle in Cohort B.
analyzed count
41
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02443324-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0001
arm key
OG001
arm label
Cohort A1
regimen
Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02443324-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0001
arm key
OG002
arm label
Cohort A2
regimen
Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02443324-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0001
arm key
OG003
arm label
Cohort C
regimen
Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
analyzed count
27
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02443324-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0001
arm key
OG004
arm label
Cohort D
regimen
Participants with Urothelial cancer (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
analyzed count
24
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02443324-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0001
arm key
OG005
arm label
Cohort E
regimen
Participants with NSCLC cancer (First L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02443324-om-0001#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0002
arm key
OG000
arm label
Cohort A and B
regimen
Participants with Gastric-GEJ cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle in Cohort A. Participants with Gastric-GEJ cancer (Second-Third L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle in Cohort B.
analyzed count
41
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02443324-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0002
arm key
OG001
arm label
Cohort A1
regimen
Participants with BTC cancer (Second-Third L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02443324-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0002
arm key
OG002
arm label
Cohort A2
regimen
Participants with Gastric-GEJ cancer (First L) received 8 mg/kg ramucirumab given IV on day 1 and 8 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02443324-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
outcome key
om-0002
arm key
OG003
arm label
Cohort C
regimen
Participants with NSCLC (Second-Fourth L) received 10 mg/kg ramucirumab given IV on day 1 in combination with 200 mg pembrolizumab given IV on day 1 Q3W of a 21-day cycle.
analyzed count
27
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02443324-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
harm key
EG000
source section id
NCT02443324-ae
event group key
EG000
event group label
Cohort A
serious affected
10
serious at risk
24
other affected
23
other at risk
24
frequency threshold
5
collection period
Baseline Up to 5.9 Years
event definition
All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
harm key
EG001
source section id
NCT02443324-ae
event group key
EG001
event group label
Cohort A1
serious affected
15
serious at risk
26
other affected
26
other at risk
26
frequency threshold
5
collection period
Baseline Up to 5.9 Years
event definition
All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
harm key
EG002
source section id
NCT02443324-ae
event group key
EG002
event group label
Cohort A2
serious affected
16
serious at risk
28
other affected
28
other at risk
28
frequency threshold
5
collection period
Baseline Up to 5.9 Years
event definition
All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
harm key
EG003
source section id
NCT02443324-ae
event group key
EG003
event group label
Cohort B
serious affected
10
serious at risk
17
other affected
16
other at risk
17
frequency threshold
5
collection period
Baseline Up to 5.9 Years
event definition
All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
harm key
EG004
source section id
NCT02443324-ae
event group key
EG004
event group label
Cohort C
serious affected
15
serious at risk
27
other affected
27
other at risk
27
frequency threshold
5
collection period
Baseline Up to 5.9 Years
event definition
All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
harm key
EG005
source section id
NCT02443324-ae
event group key
EG005
event group label
Cohort D
serious affected
16
serious at risk
24
other affected
24
other at risk
24
frequency threshold
5
collection period
Baseline Up to 5.9 Years
event definition
All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gastroesophageal-junction-carcinoma
nct id
NCT02443324
harm key
EG006
source section id
NCT02443324-ae
event group key
EG006
event group label
Cohort E
serious affected
14
serious at risk
26
other affected
26
other at risk
26
frequency threshold
5
collection period
Baseline Up to 5.9 Years
event definition
All enrolled participants who received at least one dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice