Trial Outcomes & Findings for Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)-Japan Extension Study (NCT NCT03950674)

Last Updated: 2024-06-10

Results Overview

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, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 is presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

Up to approximately 31 months

Results posted on

2024-06-10

Participant Flow

The Japanese Extension study for MK-3475-189 enrolled a total of 30 participants and the analyses included 10 participants (pembrolizumab =4; control = 6) that had been previously enrolled in the global study for MK-3475-189 (NCT02578680), resulting in a total of 40 participants.

Four participants randomized to placebo treatment had switched over to receive pembrolizumab monotherapy. Participants receiving pembrolizumab in the first course and those who switched over from placebo to pembrolizumab were eligible to receive a second course of pembrolizumab if they met certain criteria. Data from the second course treatment contributed to safety data only. Final analyses for all primary and secondary outcome measures were done at the protocol-specified cutoff (20-May-2019).

Participant milestones

Participant milestones
Measure	Pembrolizumab With Pemetrexed and Platinum Chemotherapy Followed by Pembrolizumab and Pemetrexed Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Placebo With Pemetrexed and Platinum Chemotherapy Followed by Placebo and Pemetrexed Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received saline placebo, but experienced disease progression, were switched over to pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 2 years. The participants who had switched over to pembrolizumab 200 mg IV Q3W, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.
Overall Study STARTED	25	15
Overall Study Treated	25	15
Overall Study Switched to Pembrolizumab Monotherapy	0	4
Overall Study Second Course Treatment With Pembrolizumab Monotherapy	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	25	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab With Pemetrexed and Platinum Chemotherapy Followed by Pembrolizumab and Pemetrexed Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Placebo With Pemetrexed and Platinum Chemotherapy Followed by Placebo and Pemetrexed Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received saline placebo, but experienced disease progression, were switched over to pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 2 years. The participants who had switched over to pembrolizumab 200 mg IV Q3W, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.
Overall Study Death	16	15
Overall Study Participation in the study terminated by the sponsor	9	0

Baseline Characteristics

Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)-Japan Extension Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab With Pemetrexed and Platinum Chemotherapy Followed by Pembrolizumab and Pemetrexed n=25 Participants Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Placebo With Pemetrexed and Platinum Chemotherapy Followed by Placebo and Pemetrexed n=15 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received saline placebo, but experienced disease progression, were switched over to pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 2 years. The participants who had switched over to pembrolizumab 200 mg IV Q3W, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Total n=40 Participants Total of all reporting groups
Age, Continuous	59.6 Years STANDARD_DEVIATION 12.7 • n=5 Participants	60.9 Years STANDARD_DEVIATION 11.8 • n=7 Participants	60.1 Years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	12 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	15 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	25 Participants n=5 Participants	15 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status TPS <1%	14 Participants n=5 Participants	6 Participants n=7 Participants	20 Participants n=5 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status TPS ≥1%	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Programmed Cell Death-Ligand 1 (PD-L1) Tumor Status Not Evaluable	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Platinum Chemotherapy Cisplatin	18 Participants n=5 Participants	8 Participants n=7 Participants	26 Participants n=5 Participants
Platinum Chemotherapy Carboplatin	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Smoking Status Never Smoker	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Smoking Status Former/Current Smoker	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 31 months

Population: The analysis population consisted of all randomized participants.

Outcome measures

Outcome measures
Measure	Pembrolizumab With Pemetrexed and Platinum Chemotherapy Followed by Pembrolizumab and Pemetrexed n=25 Participants Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Placebo With Pemetrexed and Platinum Chemotherapy Followed by Placebo and Pemetrexed n=15 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received saline placebo, but experienced disease progression, were switched over to pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 2 years. The participants who had switched over to pembrolizumab 200 mg IV Q3W, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging	16.5 Months Interval 8.8 to 21.1	7.1 Months Interval 4.7 to 21.4

PRIMARY outcome

Timeframe: Up to approximately 31 months

Population: The analysis population consisted of all randomized participants.

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. The OS is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab With Pemetrexed and Platinum Chemotherapy Followed by Pembrolizumab and Pemetrexed n=25 Participants Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Placebo With Pemetrexed and Platinum Chemotherapy Followed by Placebo and Pemetrexed n=15 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received saline placebo, but experienced disease progression, were switched over to pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 2 years. The participants who had switched over to pembrolizumab 200 mg IV Q3W, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.
Overall Survival (OS)	NA Months NA=Median OS not reached NA=Lower Limit OS not reached NA=Upper Limit OS not reached	25.9 Months Interval 11.9 to 29.0

SECONDARY outcome

Timeframe: Up to approximately 31 months

Population: The analysis population consisted of all randomized participants.

ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab With Pemetrexed and Platinum Chemotherapy Followed by Pembrolizumab and Pemetrexed n=25 Participants Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Placebo With Pemetrexed and Platinum Chemotherapy Followed by Placebo and Pemetrexed n=15 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received saline placebo, but experienced disease progression, were switched over to pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 2 years. The participants who had switched over to pembrolizumab 200 mg IV Q3W, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.
Overall Response Rate (ORR) Per RECIST 1.1 as Assessed by Blinded Central Imaging	56.0 Percentage of Participants Interval 34.9 to 75.6	33.3 Percentage of Participants Interval 11.8 to 61.6

SECONDARY outcome

Timeframe: Up to approximately 31 months

Population: The analysis population consisted of all randomized participants who experienced a confirmed CR or confirmed PR.

For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, 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. Note: The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR per RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab With Pemetrexed and Platinum Chemotherapy Followed by Pembrolizumab and Pemetrexed n=14 Participants Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Placebo With Pemetrexed and Platinum Chemotherapy Followed by Placebo and Pemetrexed n=5 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received saline placebo, but experienced disease progression, were switched over to pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 2 years. The participants who had switched over to pembrolizumab 200 mg IV Q3W, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.
Duration of Response (DOR) Per RECIST 1.1 as Assessed by Blinded Central Imaging	13.6 Months Interval 5.9 to 19.6	9.7 Months Interval 3.4 to NA=Upper Limit DOR not reached

SECONDARY outcome

Timeframe: Up to approximately 24 months

Population: The analysis population consisted of all randomized participants who received ≥1 dose of study drug.

An adverse event was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical product which did not necessarily have a causal relationship with this treatment. An adverse event was any unfavourable and unintended sign (including an abnormal laboratory finding, for example), 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 (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the study drug was also an adverse event. Per protocol, final analysis for this outcome measure was performed for the first course of pembrolizumab or placebo treatment. The number of participants who experienced an AE is reported.

Outcome measures

Outcome measures
Measure	Pembrolizumab With Pemetrexed and Platinum Chemotherapy Followed by Pembrolizumab and Pemetrexed n=25 Participants Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Placebo With Pemetrexed and Platinum Chemotherapy Followed by Placebo and Pemetrexed n=15 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received saline placebo, but experienced disease progression, were switched over to pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 2 years. The participants who had switched over to pembrolizumab 200 mg IV Q3W, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.
Number of Participants Who Experienced an Adverse Event (AE)	25 Participants	15 Participants

SECONDARY outcome

Timeframe: Up to approximately 21 months

Population: The analysis population consisted of all randomized participants who received ≥1 dose of study drug.

Outcome measures

Outcome measures
Measure	Pembrolizumab With Pemetrexed and Platinum Chemotherapy Followed by Pembrolizumab and Pemetrexed n=25 Participants Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Placebo With Pemetrexed and Platinum Chemotherapy Followed by Placebo and Pemetrexed n=15 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received saline placebo, but experienced disease progression, were switched over to pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 2 years. The participants who had switched over to pembrolizumab 200 mg IV Q3W, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.
Number of Participants Who Discontinued Any Study Drug Due to an AE	9 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to approximately 31 months

Population: The analysis population consisted of all randomized participants.

PFS was defined as the time from randomization to the first documented immune-related progressive disease (irPD) or death due to any cause, whichever occurred first. Per irRECIST, irPD was confirmed if any of the following are observed in 2 scans performed at least 4 weeks apart: target lesion sum of diameters remains ≥20 % and at least 5 mm absolute increase compared to nadir; non-target disease resulting in initial PD is qualitatively worse; new lesion resulting in initial irPD is qualitatively worse; additional new lesion(s) since last evaluation; or additional new non-target lesion progression since last evaluation. The PFS per irRECIST 1.1 is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab With Pemetrexed and Platinum Chemotherapy Followed by Pembrolizumab and Pemetrexed n=25 Participants Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Placebo With Pemetrexed and Platinum Chemotherapy Followed by Placebo and Pemetrexed n=15 Participants Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received saline placebo, but experienced disease progression, were switched over to pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 2 years. The participants who had switched over to pembrolizumab 200 mg IV Q3W, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.
Progression-Free Survival (PFS) as Assessed by Investigator Immune-related RECIST (irRECIST) Response Criteria	13.7 Months Interval 6.4 to 22.0	7.6 Months Interval 2.6 to 11.9

Adverse Events

Pembrolizumab With Pemetrexed and Platinum Chemotherapy Followed by Pembrolizumab and Pemetrexed

Serious events: 9 serious events

Other events: 25 other events

Deaths: 15 deaths

Placebo With Pemetrexed and Platinum Chemotherapy Followed by Placebo and Pemetrexed

Serious events: 6 serious events

Other events: 15 other events

Deaths: 11 deaths

Placebo Switched Over to Pembrolizumab Monotherapy

Serious events: 1 serious events

Other events: 4 other events

Deaths: 4 deaths

Second Course Treatment for the Pembrolizumab With Pemetrexed and Platinum Chemotherapy Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Second Course Treatment for the Placebo Switched Over to Pembrolizumab Monotherapy Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab With Pemetrexed and Platinum Chemotherapy Followed by Pembrolizumab and Pemetrexed n=25 participants at risk Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Placebo With Pemetrexed and Platinum Chemotherapy Followed by Placebo and Pemetrexed n=15 participants at risk Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received saline placebo, but experienced disease progression, were switched over to pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 2 years. The participants who had switched over to pembrolizumab 200 mg IV Q3W, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Placebo Switched Over to Pembrolizumab Monotherapy n=4 participants at risk Qualified participants who received saline placebo with pemetrexed and platinum chemotherapy followed by placebo and pemetrexed, and who experienced disease progression, were switched over to receive pembrolizumab monotherapy 200 mg IV on Day 1 Q3W for up to 2 years.	Second Course Treatment for the Pembrolizumab With Pemetrexed and Platinum Chemotherapy Arm n=1 participants at risk Participants who received pembrolizumab with pemetrexed and platinum chemotherapy followed by pembrolizumab and pemetrexed during the initial treatment, and met certain criteria, initiated a second course of pembrolizumab monotherapy at 200 mg IV Q3W for up to 1 additional year.	Second Course Treatment for the Placebo Switched Over to Pembrolizumab Monotherapy Arm Participants who were switched from saline placebo to receive pembrolizumab monotherapy, and met certain criteria, initiated a second course of pembrolizumab monotherapy at 200 mg IV Q3W for up to 1 additional year.
Endocrine disorders Adrenal insufficiency	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Gastrointestinal disorders Diarrhoea	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
General disorders Pyrexia	8.0% 2/25 • Number of events 4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Hepatobiliary disorders Hepatic function abnormal	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Infections and infestations Bacterial infection	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Infections and infestations Oesophageal infection	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Infections and infestations Parotitis	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Injury, poisoning and procedural complications Radiation oesophagitis	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Musculoskeletal and connective tissue disorders Arthralgia	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Musculoskeletal and connective tissue disorders Myalgia	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Nervous system disorders Brain oedema	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Nervous system disorders Cerebral haemorrhage	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Nervous system disorders Polyneuropathy	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Renal and urinary disorders Acute kidney injury	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	13.3% 2/15 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	25.0% 1/4 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Vascular disorders Deep vein thrombosis	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.

Other adverse events

Other adverse events
Measure	Pembrolizumab With Pemetrexed and Platinum Chemotherapy Followed by Pembrolizumab and Pemetrexed n=25 participants at risk Participants received pembrolizumab 200 mg intravenously (IV) PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin Area Under the Curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Placebo With Pemetrexed and Platinum Chemotherapy Followed by Placebo and Pemetrexed n=15 participants at risk Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. Participants who received saline placebo, but experienced disease progression, were switched over to pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 2 years. The participants who had switched over to pembrolizumab 200 mg IV Q3W, but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to another year.	Placebo Switched Over to Pembrolizumab Monotherapy n=4 participants at risk Qualified participants who received saline placebo with pemetrexed and platinum chemotherapy followed by placebo and pemetrexed, and who experienced disease progression, were switched over to receive pembrolizumab monotherapy 200 mg IV on Day 1 Q3W for up to 2 years.	Second Course Treatment for the Pembrolizumab With Pemetrexed and Platinum Chemotherapy Arm n=1 participants at risk Participants who received pembrolizumab with pemetrexed and platinum chemotherapy followed by pembrolizumab and pemetrexed during the initial treatment, and met certain criteria, initiated a second course of pembrolizumab monotherapy at 200 mg IV Q3W for up to 1 additional year.	Second Course Treatment for the Placebo Switched Over to Pembrolizumab Monotherapy Arm Participants who were switched from saline placebo to receive pembrolizumab monotherapy, and met certain criteria, initiated a second course of pembrolizumab monotherapy at 200 mg IV Q3W for up to 1 additional year.
Blood and lymphatic system disorders Anaemia	44.0% 11/25 • Number of events 17 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	66.7% 10/15 • Number of events 11 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Blood and lymphatic system disorders Leukopenia	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	46.7% 7/15 • Number of events 13 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	13.3% 2/15 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Blood and lymphatic system disorders Neutropenia	12.0% 3/25 • Number of events 5 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	20.0% 3/15 • Number of events 8 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Blood and lymphatic system disorders Thrombocytopenia	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	26.7% 4/15 • Number of events 5 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Ear and labyrinth disorders Hypoacusis	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Ear and labyrinth disorders Tinnitus	12.0% 3/25 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Endocrine disorders Hyperthyroidism	8.0% 2/25 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Endocrine disorders Hypothyroidism	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Eye disorders Conjunctivitis allergic	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Eye disorders Dry eye	8.0% 2/25 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Eye disorders Lacrimation increased	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Eye disorders Periorbital oedema	12.0% 3/25 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Gastrointestinal disorders Bowel movement irregularity	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Gastrointestinal disorders Constipation	64.0% 16/25 • Number of events 22 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	73.3% 11/15 • Number of events 18 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Gastrointestinal disorders Dental caries	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Gastrointestinal disorders Diarrhoea	32.0% 8/25 • Number of events 9 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	13.3% 2/15 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	25.0% 1/4 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Gastrointestinal disorders Dry mouth	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Gastrointestinal disorders Large intestine polyp	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Gastrointestinal disorders Nausea	72.0% 18/25 • Number of events 41 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	53.3% 8/15 • Number of events 19 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	25.0% 1/4 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Gastrointestinal disorders Oral hyperaesthesia	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Gastrointestinal disorders Stomatitis	28.0% 7/25 • Number of events 9 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	26.7% 4/15 • Number of events 7 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Gastrointestinal disorders Vomiting	8.0% 2/25 • Number of events 4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	26.7% 4/15 • Number of events 6 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
General disorders Face oedema	20.0% 5/25 • Number of events 6 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
General disorders Fatigue	16.0% 4/25 • Number of events 4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	33.3% 5/15 • Number of events 7 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
General disorders Infusion site extravasation	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
General disorders Localised oedema	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
General disorders Malaise	20.0% 5/25 • Number of events 9 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	26.7% 4/15 • Number of events 6 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
General disorders Oedema peripheral	8.0% 2/25 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	33.3% 5/15 • Number of events 6 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
General disorders Puncture site pain	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
General disorders Pyrexia	12.0% 3/25 • Number of events 7 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	25.0% 1/4 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Hepatobiliary disorders Hepatic function abnormal	8.0% 2/25 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Infections and infestations Conjunctivitis	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Infections and infestations Enterocolitis infectious	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Infections and infestations Herpes zoster	12.0% 3/25 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Infections and infestations Influenza	8.0% 2/25 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Infections and infestations Lymph gland infection	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Infections and infestations Nasopharyngitis	20.0% 5/25 • Number of events 11 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Infections and infestations Oral candidiasis	8.0% 2/25 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Infections and infestations Pharyngitis	8.0% 2/25 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Infections and infestations Upper respiratory tract infection	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Injury, poisoning and procedural complications Contusion	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Injury, poisoning and procedural complications Wound	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Investigations Alanine aminotransferase increased	36.0% 9/25 • Number of events 14 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	33.3% 5/15 • Number of events 6 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Investigations Aspartate aminotransferase increased	32.0% 8/25 • Number of events 11 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	33.3% 5/15 • Number of events 6 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Investigations Blood bilirubin increased	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Investigations Blood creatinine increased	8.0% 2/25 • Number of events 4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Investigations Creatinine renal clearance decreased	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Investigations Lymphocyte count decreased	28.0% 7/25 • Number of events 22 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Investigations Neutrophil count decreased	28.0% 7/25 • Number of events 14 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	13.3% 2/15 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Investigations Platelet count decreased	12.0% 3/25 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	13.3% 2/15 • Number of events 5 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Investigations Thyroid hormones decreased	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Investigations Thyroxine free increased	8.0% 2/25 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Investigations Tri-iodothyronine free decreased	8.0% 2/25 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Investigations Weight increased	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Investigations White blood cell count decreased	40.0% 10/25 • Number of events 20 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	20.0% 3/15 • Number of events 4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Metabolism and nutrition disorders Decreased appetite	56.0% 14/25 • Number of events 20 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	60.0% 9/15 • Number of events 23 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Metabolism and nutrition disorders Diabetes mellitus	12.0% 3/25 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Metabolism and nutrition disorders Hyperglycaemia	8.0% 2/25 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Metabolism and nutrition disorders Hyperkalaemia	8.0% 2/25 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Metabolism and nutrition disorders Hypokalaemia	8.0% 2/25 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Metabolism and nutrition disorders Hyponatraemia	12.0% 3/25 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	25.0% 1/4 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Musculoskeletal and connective tissue disorders Back pain	16.0% 4/25 • Number of events 4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	13.3% 2/15 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Musculoskeletal and connective tissue disorders Myalgia	8.0% 2/25 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/15 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	13.3% 2/15 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Nervous system disorders Dizziness	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Nervous system disorders Dysgeusia	12.0% 3/25 • Number of events 6 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	33.3% 5/15 • Number of events 9 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	25.0% 1/4 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Nervous system disorders Headache	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	13.3% 2/15 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Nervous system disorders Leukoencephalopathy	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Nervous system disorders Memory impairment	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Nervous system disorders Peripheral sensory neuropathy	12.0% 3/25 • Number of events 3 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	13.3% 2/15 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Nervous system disorders Somnolence	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Psychiatric disorders Anxiety	4.0% 1/25 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	20.0% 3/15 • Number of events 4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Psychiatric disorders Insomnia	24.0% 6/25 • Number of events 8 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Renal and urinary disorders Dysuria	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Renal and urinary disorders Renal impairment	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.0% 2/25 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Respiratory, thoracic and mediastinal disorders Hiccups	28.0% 7/25 • Number of events 11 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	33.3% 5/15 • Number of events 5 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	25.0% 1/4 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Skin and subcutaneous tissue disorders Alopecia	16.0% 4/25 • Number of events 5 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Skin and subcutaneous tissue disorders Dermatitis acneiform	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Skin and subcutaneous tissue disorders Dry skin	36.0% 9/25 • Number of events 9 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	13.3% 2/15 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Skin and subcutaneous tissue disorders Pruritus	4.0% 1/25 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Skin and subcutaneous tissue disorders Rash	24.0% 6/25 • Number of events 6 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	25.0% 1/4 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Skin and subcutaneous tissue disorders Rash maculo-papular	8.0% 2/25 • Number of events 4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 2 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Vascular disorders Deep vein thrombosis	0.00% 0/25 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.
Vascular disorders Hypertension	12.0% 3/25 • Number of events 4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	6.7% 1/15 • Number of events 1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/4 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	0.00% 0/1 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.	— 0/0 • Up to approximately 80 months All participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an adverse event (AE) unless treatment related. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment were excluded. All-cause mortality and AEs analyzed for both study arms, participants switched over from placebo to pembrolizumab, and those who received second course pembrolizumab if applicable.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Publication restrictions are in place

Restriction type: OTHER