Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

Draft scope assessment: unclear. Attached because the study's own record names HER2 and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population included all randomized participants.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population included randomized participants with a PD-L1 CPS of ≥1.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population included randomized participants with a PD-L1 CPS of ≥10.

→

secondary · POSTED

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population included all randomized participants.

→

secondary · POSTED

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population included randomized participants with a PD-L1 CPS ≥1.

→

secondary · POSTED

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population included randomized participants with a PD-L1 CPS ≥10.

→

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-gastric-cancer-kanjinti-39193c4a
nct id: NCT03675737
trial label: Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)
applicability: unclear
applicability note: Attached because the study's own record names HER2 and describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0000
source section id
NCT03675737-om-0000
source outcome index
0
endpoint
Overall Survival (OS) in All Participants
endpoint definition
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
time origin
Up to 45.9 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population included all randomized participants.
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-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0001
source section id
NCT03675737-om-0001
source outcome index
1
endpoint
Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
endpoint definition
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
time origin
Up to 45.9 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population included randomized participants with a PD-L1 CPS of ≥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-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0002
source section id
NCT03675737-om-0002
source outcome index
2
endpoint
Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
endpoint definition
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
time origin
Up to 45.9 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population included randomized participants with a PD-L1 CPS of ≥10.
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-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0003
source section id
NCT03675737-om-0003
source outcome index
3
endpoint
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in All Participants
endpoint definition
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.
time origin
Up to 49.5 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population included all randomized participants.
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-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0004
source section id
NCT03675737-om-0004
source outcome index
4
endpoint
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
endpoint definition
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.
time origin
Up to 49.5 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population included randomized participants with a PD-L1 CPS ≥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-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0005
source section id
NCT03675737-om-0005
source outcome index
5
endpoint
Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessed by Blinded Independent Central Review (BICR) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
endpoint definition
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 as assessed by BICR, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. PFS was estimated using the product-limit (Kaplan-Meier) method for censored data.
time origin
Up to 49.5 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The analysis population included randomized participants with a PD-L1 CPS ≥10.
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-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0000
arm key
OG000
arm label
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
regimen
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
analyzed count
790
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03675737-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0000
arm key
OG001
arm label
Placebo + Chemotherapy (FP or CAPOX Regimen)
regimen
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
analyzed count
789
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03675737-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0001
arm key
OG000
arm label
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
regimen
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
analyzed count
618
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03675737-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0001
arm key
OG001
arm label
Placebo + Chemotherapy (FP or CAPOX Regimen)
regimen
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
analyzed count
617
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03675737-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0002
arm key
OG000
arm label
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
regimen
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
analyzed count
279
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03675737-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0002
arm key
OG001
arm label
Placebo + Chemotherapy (FP or CAPOX Regimen)
regimen
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
analyzed count
272
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03675737-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0003
arm key
OG000
arm label
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
regimen
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
analyzed count
790
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03675737-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0003
arm key
OG001
arm label
Placebo + Chemotherapy (FP or CAPOX Regimen)
regimen
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
analyzed count
789
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03675737-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0004
arm key
OG000
arm label
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
regimen
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
analyzed count
618
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03675737-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0004
arm key
OG001
arm label
Placebo + Chemotherapy (FP or CAPOX Regimen)
regimen
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
analyzed count
617
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03675737-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0005
arm key
OG000
arm label
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
regimen
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
analyzed count
279
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03675737-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
outcome key
om-0005
arm key
OG001
arm label
Placebo + Chemotherapy (FP or CAPOX Regimen)
regimen
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
analyzed count
272
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03675737-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
harm key
EG000
source section id
NCT03675737-ae
event group key
EG000
event group label
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
serious affected
358
serious at risk
785
other affected
755
other at risk
785
frequency threshold
5
collection period
Up to approximately 49.3 months
event definition
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
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-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
harm key
EG001
source section id
NCT03675737-ae
event group key
EG001
event group label
Placebo + Chemotherapy (FP or CAPOX Regimen)
serious affected
317
serious at risk
787
other affected
751
other at risk
787
frequency threshold
5
collection period
Up to approximately 49.3 months
event definition
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
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-gastric-cancer-kanjinti-39193c4a
nct id
NCT03675737
harm key
EG002
source section id
NCT03675737-ae
event group key
EG002
event group label
Pembrolizumab Second Course
serious affected
1
serious at risk
12
other affected
10
other at risk
12
frequency threshold
5
collection period
Up to approximately 49.3 months
event definition
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
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