Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181) (NCT NCT02564263)

NCT ID: NCT02564263

Last Updated: 2023-03-13

Results Overview

OS was defined as the time from randomization to death due to any cause. Median OS in participants with SCC of the esophagus is presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

628 participants

Primary outcome timeframe

Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)

Results posted on

2023-03-13

Participant Flow

At the time of the primary analysis data cut-off of 15-Oct-2018, 67 participants were ongoing in the study.

Participant milestones

Participant milestones
Measure	Pembrolizumab Participants received pembrolizumab 200 mg, intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Overall Study STARTED	314	314
Overall Study Treated	314	296
Overall Study Received Second Course of Pembrolizumab	5	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	314	314

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab Participants received pembrolizumab 200 mg, intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Overall Study Adverse Event	31	29
Overall Study Death	270	262
Overall Study Withdrawal by Subject	4	19
Overall Study Sponsor's decision	9	4

Baseline Characteristics

Study of Pembrolizumab (MK-3475) Versus Investigator's Choice Standard Therapy for Participants With Advanced Esophageal/ Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab n=314 Participants Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy n=314 Participants Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).	Total n=628 Participants Total of all reporting groups
Age, Continuous	62.6 Years STANDARD_DEVIATION 9.4 • n=5 Participants	62.0 Years STANDARD_DEVIATION 9.6 • n=7 Participants	62.3 Years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	43 Participants n=7 Participants	84 Participants n=5 Participants
Sex: Female, Male Male	273 Participants n=5 Participants	271 Participants n=7 Participants	544 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants	25 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	288 Participants n=5 Participants	273 Participants n=7 Participants	561 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	16 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	126 Participants n=5 Participants	122 Participants n=7 Participants	248 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	179 Participants n=5 Participants	172 Participants n=7 Participants	351 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	11 Participants n=7 Participants	15 Participants n=5 Participants
Programmed Death-Ligand 1 (PD-L1) Status: Combined Positive Score (CPS) PD-L1 CPS ≥10	109 Participants n=5 Participants	117 Participants n=7 Participants	226 Participants n=5 Participants
Programmed Death-Ligand 1 (PD-L1) Status: Combined Positive Score (CPS) PD-L1 CPS <10	199 Participants n=5 Participants	194 Participants n=7 Participants	393 Participants n=5 Participants
Programmed Death-Ligand 1 (PD-L1) Status: Combined Positive Score (CPS) Not Evaluable	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Geographic Region Asia	121 Participants n=5 Participants	122 Participants n=7 Participants	243 Participants n=5 Participants
Geographic Region RoW	193 Participants n=5 Participants	192 Participants n=7 Participants	385 Participants n=5 Participants
Tumor Histology Squamous cell carcinoma	199 Participants n=5 Participants	204 Participants n=7 Participants	403 Participants n=5 Participants
Tumor Histology Adenocarcinoma of esophagus & EGJ Siewert type I	115 Participants n=5 Participants	110 Participants n=7 Participants	225 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)

Population: The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.

OS was defined as the time from randomization to death due to any cause. Median OS in participants with SCC of the esophagus is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=198 Participants Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy n=203 Participants Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Overall Survival (OS) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus	8.2 Months Interval 6.7 to 10.3	7.1 Months Interval 6.1 to 8.2

PRIMARY outcome

Timeframe: Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)

Population: The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.

OS was defined as the time from randomization to death due to any cause. Median OS in participants with a PD-L1 CPS ≥10 is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=107 Participants Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy n=115 Participants Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Overall Survival (OS) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)	9.3 Months Interval 6.6 to 12.5	6.7 Months Interval 5.1 to 8.2

PRIMARY outcome

Timeframe: Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)

Population: The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.

OS was defined as the time from randomization to death due to any cause. Median OS in all participants is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=314 Participants Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy n=314 Participants Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Overall Survival (OS) in All Participants	7.1 Months Interval 6.2 to 8.1	7.1 Months Interval 6.3 to 8.0

SECONDARY outcome

Timeframe: Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)

Population: The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.

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. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 in all participants is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=314 Participants Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy n=314 Participants Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants	2.1 Months Interval 2.1 to 2.2	3.4 Months Interval 2.8 to 3.9

SECONDARY outcome

Timeframe: Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)

Population: The efficacy analysis population consisted of all randomized participants. Participants were included in the treatment group to which they were randomized.

ORR was defined as the percentage of participants 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) as assessed using RECIST 1.1. The percentage of all participants who experienced a CR or PR is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=314 Participants Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy n=314 Participants Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in All Participants	13.1 Percentage of Participants Interval 9.5 to 17.3	6.7 Percentage of Participants Interval 4.2 to 10.0

SECONDARY outcome

Timeframe: Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)

Population: The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.

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. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 is presented for participants with SCC of the esophagus.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=198 Participants Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy n=203 Participants Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus	2.2 Months Interval 2.1 to 3.2	3.1 Months Interval 2.2 to 3.9

SECONDARY outcome

Timeframe: Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)

Population: The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.

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. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. Median PFS as assessed by blinded independent central review per RECIST 1.1 is presented for participants with a PD-L1 CPS ≥10.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=107 Participants Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy n=115 Participants Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)	2.6 Months Interval 2.1 to 4.1	3.0 Months Interval 2.1 to 3.7

SECONDARY outcome

Timeframe: Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)

Population: The efficacy analysis population consisted of all randomized participants with SCC of the esophagus. Participants were included in the treatment group to which they were randomized.

ORR was defined as the percentage of participants 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) as assessed using RECIST 1.1. The percentage of participants with SCC of the esophagus who experienced a CR or PR is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=198 Participants Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy n=203 Participants Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Squamous Cell Carcinoma (SCC) of the Esophagus	16.7 Percentage of Participants Interval 11.8 to 22.6	7.4 Percentage of Participants Interval 4.2 to 11.9

SECONDARY outcome

Timeframe: Through Final Analysis data cutoff date of 15-Oct-2018 (up to approximately 34 months)

Population: The efficacy analysis population consisted of all randomized participants with a PD-L1 CPS ≥10. Participants were included in the treatment group to which they were randomized.

ORR was defined as the percentage of participants 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) as assessed using RECIST 1.1. The percentage of participants with a PD-L1 CPS ≥10 who experienced a CR or PR is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=107 Participants Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy n=115 Participants Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With Programmed Death-Ligand 1 Combined Positive Score ≥10 (PD-L1 CPS ≥10)	21.5 Percentage of Participants Interval 14.1 to 30.5	6.1 Percentage of Participants Interval 2.5 to 12.1

SECONDARY outcome

Timeframe: Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years)

Population: The analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were included in the treatment group to which they were randomized.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who experienced ≥1 AE is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=314 Participants Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy n=296 Participants Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Number of Participants Experiencing an Adverse Event (AE)	301 Participants	288 Participants

SECONDARY outcome

Timeframe: Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years)

Population: The analysis population consisted of all randomized participants who received at least 1 dose of study treatment. Participants were included in the treatment group to which they were randomized.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who discontinued study treatment due to an AE is presented.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=314 Participants Participants received pembrolizumab 200 mg IV on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy n=296 Participants Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).
Number of Participants Discontinuing Study Treatment Due an Adverse Event (AE)	40 Participants	42 Participants

Adverse Events

Pembrolizumab First Course

Serious events: 127 serious events

Other events: 285 other events

Deaths: 305 deaths

Chemotherapy

Serious events: 121 serious events

Other events: 281 other events

Deaths: 305 deaths

Pembrolizumab Second Course

Serious events: 1 serious events

Other events: 5 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab First Course n=314 participants at risk Participants received pembrolizumab 200 mg, intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy n=296 participants at risk Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).	Pembrolizumab Second Course n=5 participants at risk Qualified participants who received pembrolizumab as a first course and stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
Blood and lymphatic system disorders Anaemia	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	1.7% 5/296 • Number of events 5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Blood and lymphatic system disorders Febrile neutropenia	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	7.4% 22/296 • Number of events 24 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Blood and lymphatic system disorders Immune thrombocytopenia	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Blood and lymphatic system disorders Leukopenia	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Blood and lymphatic system disorders Neutropenia	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	1.4% 4/296 • Number of events 5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Cardiac disorders Acute left ventricular failure	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Cardiac disorders Acute myocardial infarction	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Cardiac disorders Atrial fibrillation	0.64% 2/314 • Number of events 3 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.68% 2/296 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Cardiac disorders Cardio-respiratory arrest	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Cardiac disorders Myocarditis	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Cardiac disorders Sinus tachycardia	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Cardiac disorders Tachycardia	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Congenital, familial and genetic disorders Tracheo-oesophageal fistula	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Endocrine disorders Hypercalcaemia of malignancy	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Endocrine disorders Hypophysitis	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Eye disorders Cataract	0.32% 1/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal distension	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain	0.96% 3/314 • Number of events 3 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Colitis	0.96% 3/314 • Number of events 3 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Constipation	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Diarrhoea	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	1.4% 4/296 • Number of events 4 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Diverticulum oesophageal	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Dysphagia	3.5% 11/314 • Number of events 12 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Enterocolitis	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	1.4% 4/296 • Number of events 4 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Gastrointestinal hypomotility	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Haematemesis	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Intestinal perforation	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Nausea	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	1.0% 3/296 • Number of events 3 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Oesophageal fistula	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Oesophageal haemorrhage	1.3% 4/314 • Number of events 4 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Oesophageal obstruction	0.96% 3/314 • Number of events 3 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Oesophageal perforation	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Oesophageal stenosis	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Oesophageal ulcer	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Oesophagitis	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Peritoneal adhesions	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	1.0% 3/296 • Number of events 3 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Vomiting	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	1.7% 5/296 • Number of events 5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
General disorders Asthenia	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
General disorders Chest pain	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
General disorders Death	1.6% 5/314 • Number of events 5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	3.4% 10/296 • Number of events 10 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
General disorders Fatigue	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.68% 2/296 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
General disorders General physical health deterioration	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
General disorders Pyrexia	1.3% 4/314 • Number of events 4 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	1.4% 4/296 • Number of events 4 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
General disorders Strangulated hernia	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Hepatobiliary disorders Autoimmune hepatitis	0.96% 3/314 • Number of events 3 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Hepatobiliary disorders Cholecystitis	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Hepatobiliary disorders Cholecystitis acute	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Hepatobiliary disorders Hepatic failure	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Hepatobiliary disorders Hepatic function abnormal	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Hepatobiliary disorders Immune-mediated hepatitis	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Hepatobiliary disorders Liver injury	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Appendicitis	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.68% 2/296 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Bacteraemia	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Beta haemolytic streptococcal infection	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Bronchitis	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.68% 2/296 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Candida infection	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Cellulitis	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Clostridium difficile colitis	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Device related sepsis	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Empyema	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Hepatic infection	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Herpes zoster	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.68% 2/296 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Infection	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.68% 2/296 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Liver abscess	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Lower respiratory tract infection viral	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Mediastinitis	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Peritonitis	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Pneumonia	4.5% 14/314 • Number of events 15 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	7.4% 22/296 • Number of events 26 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Pneumonia aspiration	3.8% 12/314 • Number of events 13 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	1.7% 5/296 • Number of events 5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Pneumonia bacterial	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.68% 2/296 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Pneumonia necrotising	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Pulmonary sepsis	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Respiratory tract infection	0.96% 3/314 • Number of events 3 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.68% 2/296 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Sepsis	1.3% 4/314 • Number of events 4 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	1.0% 3/296 • Number of events 4 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Septic shock	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Stoma site infection	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Subcutaneous abscess	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Tracheitis	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Tracheostomy infection	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Upper respiratory tract infection	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Urinary tract infection	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Varicella zoster virus infection	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Vascular device infection	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Injury, poisoning and procedural complications Anastomotic fistula	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Injury, poisoning and procedural complications Anastomotic leak	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Injury, poisoning and procedural complications Fall	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Injury, poisoning and procedural complications Gastrostomy failure	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Injury, poisoning and procedural complications Infusion related reaction	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Injury, poisoning and procedural complications Radiation pneumonitis	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Injury, poisoning and procedural complications Spinal compression fracture	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Injury, poisoning and procedural complications Subdural haematoma	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Injury, poisoning and procedural complications Tracheal injury	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Injury, poisoning and procedural complications Tracheal obstruction	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Injury, poisoning and procedural complications Upper limb fracture	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations Hepatic enzyme increased	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations Liver function test increased	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations Neutrophil count decreased	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	1.0% 3/296 • Number of events 3 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations Weight decreased	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations White blood cell count decreased	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.68% 2/296 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations White blood cell count increased	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.68% 2/296 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Dehydration	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	1.4% 4/296 • Number of events 4 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Electrolyte imbalance	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypercalcaemia	0.96% 3/314 • Number of events 3 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypoglycaemia	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypokalaemia	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.68% 2/296 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Fistula inflammation	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Polymyositis	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Head and neck cancer	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Bell's palsy	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Cerebellar stroke	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Cerebral infarction	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Cerebrovascular accident	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Demyelination	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Dyskinesia	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Dystonia	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Facial paralysis	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Guillain-Barre syndrome	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Haemorrhage intracranial	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Haemorrhagic stroke	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Headache	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Hemiparesis	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Neuralgia	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Neuropathy peripheral	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Radiculopathy	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Spinal cord compression	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Vocal cord paralysis	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Product Issues Device dislocation	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Product Issues Device occlusion	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Psychiatric disorders Completed suicide	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Psychiatric disorders Confusional state	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Psychiatric disorders Delirium	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Renal and urinary disorders Acute kidney injury	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Renal and urinary disorders Chronic kidney disease	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Reproductive system and breast disorders Prostatitis	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Hiccups	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.32% 1/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.68% 2/296 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.2% 7/314 • Number of events 7 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.96% 3/314 • Number of events 3 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary necrosis	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Tracheal fistula	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Upper airway obstruction	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Dermal cyst	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Vascular disorders Deep vein thrombosis	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Vascular disorders Haemorrhage	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Vascular disorders Shock haemorrhagic	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.

Other adverse events

Other adverse events
Measure	Pembrolizumab First Course n=314 participants at risk Participants received pembrolizumab 200 mg, intravenously (IV) on Day 1 of every 21-day (3-week) cycle for up to 35 administrations (up to approximately 25 months).	Chemotherapy n=296 participants at risk Participants received Investigator's choice of paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 of every 28-day (4-week) cycle, OR docetaxel 75 mg/m\^2 IV on Day 1 of every 21-day (3-week) cycle, OR irinotecan 180 mg/m\^2 IV on Day 1 of every 14-day (2-week) cycle (up to approximately 19 months).	Pembrolizumab Second Course n=5 participants at risk Qualified participants who received pembrolizumab as a first course and stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
Blood and lymphatic system disorders Anaemia	16.6% 52/314 • Number of events 60 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	28.0% 83/296 • Number of events 110 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Blood and lymphatic system disorders Neutropenia	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	12.2% 36/296 • Number of events 65 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Endocrine disorders Hypothyroidism	11.8% 37/314 • Number of events 40 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	2.4% 7/296 • Number of events 7 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal distension	2.2% 7/314 • Number of events 7 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.68% 2/296 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain	10.8% 34/314 • Number of events 36 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	9.1% 27/296 • Number of events 32 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Abdominal pain upper	4.5% 14/314 • Number of events 16 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	5.7% 17/296 • Number of events 19 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Constipation	17.8% 56/314 • Number of events 63 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	18.9% 56/296 • Number of events 63 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Diarrhoea	12.1% 38/314 • Number of events 65 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	26.7% 79/296 • Number of events 120 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Dyspepsia	1.9% 6/314 • Number of events 7 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	3.7% 11/296 • Number of events 13 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Dysphagia	12.7% 40/314 • Number of events 44 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	8.8% 26/296 • Number of events 27 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Nausea	18.8% 59/314 • Number of events 66 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	28.0% 83/296 • Number of events 110 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Stomatitis	2.9% 9/314 • Number of events 9 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	9.5% 28/296 • Number of events 30 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Gastrointestinal disorders Vomiting	11.8% 37/314 • Number of events 45 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	17.9% 53/296 • Number of events 74 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
General disorders Asthenia	14.3% 45/314 • Number of events 48 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	14.5% 43/296 • Number of events 58 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
General disorders Fatigue	21.3% 67/314 • Number of events 70 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	29.4% 87/296 • Number of events 121 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
General disorders Malaise	4.8% 15/314 • Number of events 18 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	6.4% 19/296 • Number of events 26 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
General disorders Oedema peripheral	6.1% 19/314 • Number of events 20 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	6.4% 19/296 • Number of events 19 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
General disorders Pyrexia	9.9% 31/314 • Number of events 41 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	15.2% 45/296 • Number of events 58 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Infections and infestations Upper respiratory tract infection	3.8% 12/314 • Number of events 17 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	4.4% 13/296 • Number of events 15 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations Alanine aminotransferase increased	7.0% 22/314 • Number of events 26 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	3.4% 10/296 • Number of events 16 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations Aspartate aminotransferase increased	8.3% 26/314 • Number of events 33 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	4.7% 14/296 • Number of events 16 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations Blood creatinine increased	2.5% 8/314 • Number of events 11 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	1.0% 3/296 • Number of events 4 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations Blood sodium decreased	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations Blood thyroid stimulating hormone increased	0.96% 3/314 • Number of events 4 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	1.0% 3/296 • Number of events 3 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations Lymphocyte count decreased	2.9% 9/314 • Number of events 10 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	3.0% 9/296 • Number of events 15 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations Neutrophil count decreased	0.64% 2/314 • Number of events 2 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	16.9% 50/296 • Number of events 113 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations Weight decreased	12.4% 39/314 • Number of events 39 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	11.5% 34/296 • Number of events 43 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Investigations White blood cell count decreased	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	17.6% 52/296 • Number of events 114 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Decreased appetite	24.2% 76/314 • Number of events 82 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	25.7% 76/296 • Number of events 97 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Gout	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyperglycaemia	5.1% 16/314 • Number of events 21 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	4.7% 14/296 • Number of events 14 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyperkalaemia	2.5% 8/314 • Number of events 13 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	2.0% 6/296 • Number of events 7 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypoalbuminaemia	5.4% 17/314 • Number of events 23 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	5.1% 15/296 • Number of events 16 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Hypokalaemia	4.8% 15/314 • Number of events 15 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	9.8% 29/296 • Number of events 40 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Hyponatraemia	6.1% 19/314 • Number of events 27 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	5.7% 17/296 • Number of events 24 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Metabolism and nutrition disorders Iron deficiency	0.32% 1/314 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Arthralgia	7.6% 24/314 • Number of events 26 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	6.4% 19/296 • Number of events 22 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Back pain	12.1% 38/314 • Number of events 40 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	8.1% 24/296 • Number of events 27 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Myalgia	2.5% 8/314 • Number of events 10 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	8.4% 25/296 • Number of events 31 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	2.5% 8/314 • Number of events 10 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	2.7% 8/296 • Number of events 9 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Dementia Alzheimer's type	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/296 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Neuropathy peripheral	1.9% 6/314 • Number of events 7 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	8.4% 25/296 • Number of events 28 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Nervous system disorders Peripheral sensory neuropathy	0.96% 3/314 • Number of events 3 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	17.6% 52/296 • Number of events 53 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Psychiatric disorders Insomnia	8.0% 25/314 • Number of events 25 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	5.4% 16/296 • Number of events 42 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Psychiatric disorders Irritability	0.00% 0/314 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.34% 1/296 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Cough	12.7% 40/314 • Number of events 46 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	10.1% 30/296 • Number of events 33 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.9% 31/314 • Number of events 36 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	5.7% 17/296 • Number of events 21 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Alopecia	1.3% 4/314 • Number of events 4 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	29.7% 88/296 • Number of events 88 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Pruritus	7.3% 23/314 • Number of events 27 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	2.7% 8/296 • Number of events 8 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	20.0% 1/5 • Number of events 1 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.
Skin and subcutaneous tissue disorders Rash	6.4% 20/314 • Number of events 24 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	8.4% 25/296 • Number of events 27 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.	0.00% 0/5 • Through End-of-Trial Analysis data cutoff date of 14-Mar-2022 (up to approximately 6 years) All-Cause Mortality (ACM) was reported for all randomized participants. Five participants got a second course of pembrolizumab and were monitored for AEs and ACM. Safety was analyzed in participants who got ≥1 dose of study drug. Per protocol, disease progression of cancer was not considered an AE unless considered related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug are excluded as AEs.

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 study 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