Trial Outcomes & Findings for Consolidation Pembrolizumab Following Chemoradiation in Patients With Inoperable/Unresectable Stage III NSCLC (NCT NCT02343952)

Last Updated: 2023-09-13

Results Overview

Time to Death or Distant Metastasis is defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that was outside of the radiation field according to RECIST 1.1 or proven by biopsy. The Primary objective in the study was to determine if consolidation therapy with pembrolizumab following concurrent chemoradiation improves time to death or distant metastatic disease, depending on which occurs first, in subjects with inoperable or unresectable stage IIIA or IIIB NSCLC.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

93 participants

Primary outcome timeframe

From start of treatment until death or distant metastasis (estimate 18 months) up to a maximum of 47 months.

Results posted on

2023-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Arm Pembrolizumab -200 mg IV 3 weeks Pembrolizumab: Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.
Study Treatment STARTED	93
Study Treatment COMPLETED	40
Study Treatment NOT COMPLETED	53
Follow up STARTED	83
Follow up COMPLETED	38
Follow up NOT COMPLETED	45

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Arm Pembrolizumab -200 mg IV 3 weeks Pembrolizumab: Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.
Study Treatment Disease Progression	23
Study Treatment Death	3
Study Treatment Adverse Event	19
Study Treatment Withdrawal by Subject	7
Study Treatment other complicating Diseases	1
Follow up Withdrawal by Subject	3
Follow up Death	33
Follow up Patient does not meet eligibility for study.	1
Follow up Research department closed by the practice.	5
Follow up Patient went home to Russia	1
Follow up Disease Progression	1
Follow up study terminated	1

Baseline Characteristics

Consolidation Pembrolizumab Following Chemoradiation in Patients With Inoperable/Unresectable Stage III NSCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Arm n=92 Participants Pembrolizumab -200 mg IV 3 weeks Pembrolizumab: Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.
Age, Continuous	64.4 years STANDARD_DEVIATION 8.6 • n=39 Participants
Sex: Female, Male Female	33 Participants n=39 Participants
Sex: Female, Male Male	59 Participants n=39 Participants
Race/Ethnicity, Customized Race · White	84 Participants n=39 Participants
Race/Ethnicity, Customized Race · Black or African American	3 Participants n=39 Participants
Race/Ethnicity, Customized Race · Asian	4 Participants n=39 Participants
Race/Ethnicity, Customized Race · Unknown	1 Participants n=39 Participants
Race/Ethnicity, Customized Ethnicity · Non-Hispanic	90 Participants n=39 Participants
Race/Ethnicity, Customized Ethnicity · Unknown	2 Participants n=39 Participants
Disease Stage IIIA	55 Participants n=39 Participants
Disease Stage IIIB	37 Participants n=39 Participants
Tumor Histologic Type Squamous	41 Participants n=39 Participants
Tumor Histologic Type Non-Squamous	51 Participants n=39 Participants
Smoking Status Current smoker	16 Participants n=39 Participants
Smoking Status Former smoker	71 Participants n=39 Participants
Smoking Status Never smoker	5 Participants n=39 Participants
Prior Radiation Dose	61.0 Gray STANDARD_DEVIATION 6.2 • n=39 Participants
Prior Chemo Received Cisplatin/Etoposide	24 Participants n=39 Participants
Prior Chemo Received Carboplatin/Paclitaxel	65 Participants n=39 Participants
Prior Chemo Received Cisplatin/Pemetrexed	2 Participants n=39 Participants
Prior Chemo Received Carboplatin/Paclitaxel & Carboplatin/Pemetrexed	1 Participants n=39 Participants
PD-L1 Negative	11 Participants n=39 Participants
PD-L1 Positive(1-49%)	11 Participants n=39 Participants
PD-L1 Positive(>=50%)	31 Participants n=39 Participants
PD-L1 Missing/Not collected	39 Participants n=39 Participants

PRIMARY outcome

Timeframe: From start of treatment until death or distant metastasis (estimate 18 months) up to a maximum of 47 months.

Population: This includes all subjects with exception of one subject.This patient had change in diagnosis from non-small cell carcinoma to uterine adenocarcinoma while on study. In retrospect, patient does not meet eligibility for study. Therefore, this subject was included in the safety results, but not the efficacy results.

Outcome measures

Outcome measures
Measure	Experimental Arm n=92 Participants Pembrolizumab -200 mg IV 3 weeks Pembrolizumab: Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.
Time to Death or Distant Metastasis	30.7 months Interval 18.7 to The upper limit of the confidence interval was not reached.

SECONDARY outcome

Timeframe: From start of treatment until Progression based on RECIST 1.1 or death up to a maximum value of 47 months

Progression Free Survival is defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). Progression is defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. One of the secondary objectives in the study is to determine if consolidation therapy with pembrolizumab following concurrent chemoradiation improves progression free survival in subjects with inoperable or unresectable stage IIA or IIIB non-small cell lung cancer(NSCLC). PFS has been estimated by Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Experimental Arm n=92 Participants Pembrolizumab -200 mg IV 3 weeks Pembrolizumab: Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.
Progression Free Survival	18.7 months Interval 12.4 to 33.8

SECONDARY outcome

Timeframe: From the date of randomization up to a maximum value of 47 months or death.

Overall Survival is defined as the time from the date of randomization until death due to any cause. One of the secondary objectives in the study is to determine if consolidation therapy with pembrolizumab following concurrent chemoradiation improves Overall Survival in subjects with inoperable or unresectable stage IIA or IIIB non-small cell lung cancer(NSCLC). OS has been estimated by Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Experimental Arm n=92 Participants Pembrolizumab -200 mg IV 3 weeks Pembrolizumab: Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.
Overall Survival	35.8 months Interval 24.2 to The upper limit of the confidence interval was not reached.

SECONDARY outcome

Timeframe: From the time of consent until 30 days after last dose of pembrolizumab up to a maximumof 18 months.

One of the secondary objective in this study is to assess toxicity and tolerability of pembrolizumab consolidation therapy following concurrent chemoradiation in subjects with stage IIIA or IIIB NSCLC.

Outcome measures

Outcome measures
Measure	Experimental Arm n=92 Participants Pembrolizumab -200 mg IV 3 weeks Pembrolizumab: Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.
Number of Participants Experiencing Grade 3-4 AE With Adverse Events as a Measure of Safety and Tolerability	52 Participants

Adverse Events

Experimental Arm

Serious events: 26 serious events

Other events: 93 other events

Deaths: 41 deaths

Serious adverse events

Serious adverse events
Measure	Experimental Arm n=93 participants at risk Pembrolizumab -200 mg IV 3 weeks Pembrolizumab: Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.
Cardiac disorders ATRIAL FIBRILLATION	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Immune system disorders AUTOIMMUNE DISORDER	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders BRONCHOPULMONARY HEMORRHAGE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Cardiac disorders CHEST PAIN - CARDIAC	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders DEHYDRATION	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Psychiatric disorders DEPRESSION	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
General disorders FEVER	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Injury, poisoning and procedural complications FRACTURE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Cardiac disorders HEART FAILURE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders HYPERGLYCEMIA	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders HYPOXIA	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations LUNG INFECTION	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Cardiac disorders MYOCARDIAL INFARCTION	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	7.5% 7/93 • Number of events 10 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Psychiatric disorders PSYCHIATRIC DISORDERS - OTHER, SPECIFY	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	3.2% 3/93 • Number of events 4 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Psychiatric disorders SUICIDAL IDEATION	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders VOMITING	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.

Other adverse events

Other adverse events
Measure	Experimental Arm n=93 participants at risk Pembrolizumab -200 mg IV 3 weeks Pembrolizumab: Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.
Gastrointestinal disorders ABDOMINAL PAIN	6.5% 6/93 • Number of events 6 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders ACIDOSIS	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Psychiatric disorders AGITATION	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations ALANINE AMINOTRANSFERASE INCREASED	5.4% 5/93 • Number of events 5 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations ALKALINE PHOSPHATASE INCREASED	6.5% 6/93 • Number of events 7 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Immune system disorders ALLERGIC REACTION	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders ALLERGIC RHINITIS	11.8% 11/93 • Number of events 13 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Skin and subcutaneous tissue disorders ALOPECIA	7.5% 7/93 • Number of events 7 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Blood and lymphatic system disorders ANEMIA	17.2% 16/93 • Number of events 24 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders ANOREXIA	23.7% 22/93 • Number of events 31 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Psychiatric disorders ANXIETY	21.5% 20/93 • Number of events 21 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders ARTHRALGIA	17.2% 16/93 • Number of events 29 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders ARTHRITIS	8.6% 8/93 • Number of events 9 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	7.5% 7/93 • Number of events 8 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Cardiac disorders ATRIAL FIBRILLATION	7.5% 7/93 • Number of events 7 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Immune system disorders AUTOIMMUNE DISORDER	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders BACK PAIN	30.1% 28/93 • Number of events 38 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	12.9% 12/93 • Number of events 18 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations BLOOD BILIRUBIN INCREASED	3.2% 3/93 • Number of events 3 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Eye disorders BLURRED VISION	4.3% 4/93 • Number of events 4 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders BONE PAIN	3.2% 3/93 • Number of events 4 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations BRONCHIAL INFECTION	5.4% 5/93 • Number of events 5 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders BRONCHIAL STRICTURE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Injury, poisoning and procedural complications BRUISING	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Cardiac disorders CARDIAC DISORDERS - OTHER, SPECIFY	9.7% 9/93 • Number of events 9 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Eye disorders CATARACT	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Cardiac disorders CHEST PAIN - CARDIAC	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders CHEST WALL PAIN	5.4% 5/93 • Number of events 6 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
General disorders CHILLS	8.6% 8/93 • Number of events 9 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations CHOLESTEROL HIGH	11.8% 11/93 • Number of events 12 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Renal and urinary disorders CHRONIC KIDNEY DISEASE	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Nervous system disorders COGNITIVE DISTURBANCE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders COLITIS	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Nervous system disorders CONCENTRATION IMPAIRMENT	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders CONSTIPATION	29.0% 27/93 • Number of events 29 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders COUGH	68.8% 64/93 • Number of events 124 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations CREATININE INCREASED	12.9% 12/93 • Number of events 25 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders DEHYDRATION	8.6% 8/93 • Number of events 8 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Psychiatric disorders DEPRESSION	21.5% 20/93 • Number of events 23 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders DIARRHEA	26.9% 25/93 • Number of events 44 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Nervous system disorders DIZZINESS	15.1% 14/93 • Number of events 17 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders DRY MOUTH	3.2% 3/93 • Number of events 3 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Skin and subcutaneous tissue disorders DRY SKIN	5.4% 5/93 • Number of events 6 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Nervous system disorders DYSGEUSIA	9.7% 9/93 • Number of events 10 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders DYSPEPSIA	6.5% 6/93 • Number of events 8 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders DYSPHAGIA	10.8% 10/93 • Number of events 10 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders DYSPNEA	58.1% 54/93 • Number of events 97 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Ear and labyrinth disorders EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY	5.4% 5/93 • Number of events 5 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Ear and labyrinth disorders EAR PAIN	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
General disorders EDEMA FACE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
General disorders EDEMA LIMBS	8.6% 8/93 • Number of events 9 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations EJECTION FRACTION DECREASED	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Endocrine disorders ENDOCRINE DISORDERS - OTHER, SPECIFY	5.4% 5/93 • Number of events 8 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	3.2% 3/93 • Number of events 3 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	3.2% 3/93 • Number of events 3 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Skin and subcutaneous tissue disorders ERYTHEMA MULTIFORME	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders ESOPHAGEAL PAIN	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders ESOPHAGITIS	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Eye disorders EYE DISORDERS - OTHER, SPECIFY	6.5% 6/93 • Number of events 7 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Injury, poisoning and procedural complications FALL	2.2% 2/93 • Number of events 3 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
General disorders FATIGUE	72.0% 67/93 • Number of events 115 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders FECAL INCONTINENCE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
General disorders FEVER	15.1% 14/93 • Number of events 26 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders FLANK PAIN	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Eye disorders FLASHING LIGHTS	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders FLATULENCE	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Eye disorders FLOATERS	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
General disorders FLU LIKE SYMPTOMS	4.3% 4/93 • Number of events 5 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Vascular disorders FLUSHING	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Injury, poisoning and procedural complications FRACTURE	3.2% 3/93 • Number of events 3 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
General disorders GAIT DISTURBANCE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders GASTRIC ULCER	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders GASTRITIS	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	20.4% 19/93 • Number of events 20 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	9.7% 9/93 • Number of events 16 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders GASTROINTESTINAL PAIN	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY	22.6% 21/93 • Number of events 71 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	6.5% 6/93 • Number of events 6 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Eye disorders GLAUCOMA	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations GUM INFECTION	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Nervous system disorders HEADACHE	17.2% 16/93 • Number of events 19 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Ear and labyrinth disorders HEARING IMPAIRED	3.2% 3/93 • Number of events 3 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Cardiac disorders HEART FAILURE	3.2% 3/93 • Number of events 3 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders HEMORRHOIDS	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Hepatobiliary disorders HEPATOBILIARY DISORDERS - OTHER, SPECIFY	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders HICCUPS	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders HOARSENESS	8.6% 8/93 • Number of events 8 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Vascular disorders HOT FLASHES	2.2% 2/93 • Number of events 3 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders HYPERCALCEMIA	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders HYPERGLYCEMIA	11.8% 11/93 • Number of events 14 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Vascular disorders HYPERTENSION	39.8% 37/93 • Number of events 72 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Endocrine disorders HYPERTHYROIDISM	9.7% 9/93 • Number of events 11 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders HYPERTRIGLYCERIDEMIA	1.1% 1/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders HYPOALBUMINEMIA	3.2% 3/93 • Number of events 3 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders HYPOCALCEMIA	5.4% 5/93 • Number of events 7 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders HYPOGLYCEMIA	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders HYPOKALEMIA	11.8% 11/93 • Number of events 16 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders HYPOMAGNESEMIA	9.7% 9/93 • Number of events 10 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders HYPONATREMIA	4.3% 4/93 • Number of events 7 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders HYPOPHOSPHATEMIA	6.5% 6/93 • Number of events 8 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Vascular disorders HYPOTENSION	7.5% 7/93 • Number of events 8 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Endocrine disorders HYPOTHYROIDISM	14.0% 13/93 • Number of events 19 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders HYPOXIA	3.2% 3/93 • Number of events 3 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Immune system disorders IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY	2.2% 2/93 • Number of events 3 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	5.4% 5/93 • Number of events 6 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Psychiatric disorders INSOMNIA	33.3% 31/93 • Number of events 34 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations INVESTIGATIONS - OTHER, SPECIFY	4.3% 4/93 • Number of events 6 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders JOINT RANGE OF MOTION DECREASED	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders KYPHOSIS	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders LARYNGEAL EDEMA	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations LARYNGITIS	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
General disorders LOCALIZED EDEMA	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations LUNG INFECTION	5.4% 5/93 • Number of events 5 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations LYMPHOCYTE COUNT DECREASED	8.6% 8/93 • Number of events 18 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations LYMPHOCYTE COUNT INCREASED	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
General disorders MALAISE	3.2% 3/93 • Number of events 6 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Social circumstances MENOPAUSE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY	6.5% 6/93 • Number of events 6 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations MUCOSAL INFECTION	3.2% 3/93 • Number of events 3 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders MUCOSITIS ORAL	4.3% 4/93 • Number of events 4 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders MUSCLE WEAKNESS LOWER LIMB	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	17.2% 16/93 • Number of events 27 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders MYALGIA	6.5% 6/93 • Number of events 10 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations NAIL INFECTION	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Skin and subcutaneous tissue disorders NAIL RIDGING	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	12.9% 12/93 • Number of events 12 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders NAUSEA	32.3% 30/93 • Number of events 43 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders NECK PAIN	9.7% 9/93 • Number of events 10 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Nervous system disorders NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY	18.3% 17/93 • Number of events 23 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations NEUTROPHIL COUNT DECREASED	3.2% 3/93 • Number of events 4 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
General disorders NON-CARDIAC CHEST PAIN	9.7% 9/93 • Number of events 10 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders ORAL DYSESTHESIA	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders ORAL PAIN	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations OTITIS EXTERNA	1.1% 1/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
General disorders PAIN	16.1% 15/93 • Number of events 16 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	19.4% 18/93 • Number of events 20 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations PAPULOPUSTULAR RASH	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Nervous system disorders PARESTHESIA	4.3% 4/93 • Number of events 4 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Reproductive system and breast disorders PELVIC PAIN	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Cardiac disorders PERICARDIAL EFFUSION	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders PERIODONTAL DISEASE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	5.4% 5/93 • Number of events 5 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	20.4% 19/93 • Number of events 21 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Psychiatric disorders PERSONALITY CHANGE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations PLATELET COUNT DECREASED	6.5% 6/93 • Number of events 10 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	5.4% 5/93 • Number of events 10 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders PLEURITIC PAIN	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	21.5% 20/93 • Number of events 26 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders POSTNASAL DRIP	5.4% 5/93 • Number of events 6 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	17.2% 16/93 • Number of events 21 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Reproductive system and breast disorders PROSTATIC OBSTRUCTION	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Skin and subcutaneous tissue disorders PRURITUS	18.3% 17/93 • Number of events 21 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Psychiatric disorders PSYCHIATRIC DISORDERS - OTHER, SPECIFY	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Psychiatric disorders PSYCHOSIS	2.2% 2/93 • Number of events 3 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Skin and subcutaneous tissue disorders RASH ACNEIFORM	5.4% 5/93 • Number of events 5 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	19.4% 18/93 • Number of events 35 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Renal and urinary disorders RENAL AND URINARY DISORDERS - OTHER, SPECIFY	8.6% 8/93 • Number of events 9 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	23.7% 22/93 • Number of events 38 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Psychiatric disorders RESTLESSNESS	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Nervous system disorders SEIZURE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Nervous system disorders SINUS PAIN	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Cardiac disorders SINUS TACHYCARDIA	6.5% 6/93 • Number of events 7 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations SINUSITIS	6.5% 6/93 • Number of events 10 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	22.6% 21/93 • Number of events 29 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Skin and subcutaneous tissue disorders SKIN HYPERPIGMENTATION	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations SKIN INFECTION	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Skin and subcutaneous tissue disorders SKIN ULCERATION	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders SLEEP APNEA	4.3% 4/93 • Number of events 4 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Musculoskeletal and connective tissue disorders SOFT TISSUE NECROSIS LOWER LIMB	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Nervous system disorders SOMNOLENCE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders SORE THROAT	6.5% 6/93 • Number of events 6 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Nervous system disorders STROKE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Surgical and medical procedures SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Nervous system disorders SYNCOPE	2.2% 2/93 • Number of events 4 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Vascular disorders THROMBOEMBOLIC EVENT	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Ear and labyrinth disorders TINNITUS	4.3% 4/93 • Number of events 4 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations TOOTH INFECTION	4.3% 4/93 • Number of events 4 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders TOOTHACHE	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations UPPER RESPIRATORY INFECTION	6.5% 6/93 • Number of events 7 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Renal and urinary disorders URINARY FREQUENCY	5.4% 5/93 • Number of events 5 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Infections and infestations URINARY TRACT INFECTION	6.5% 6/93 • Number of events 8 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Renal and urinary disorders URINARY TRACT PAIN	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Renal and urinary disorders URINARY URGENCY	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Renal and urinary disorders URINE DISCOLORATION	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Skin and subcutaneous tissue disorders URTICARIA	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Vascular disorders VASCULAR DISORDERS - OTHER, SPECIFY	2.2% 2/93 • Number of events 2 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders VOICE ALTERATION	2.2% 2/93 • Number of events 4 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Gastrointestinal disorders VOMITING	15.1% 14/93 • Number of events 17 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations WEIGHT GAIN	16.1% 15/93 • Number of events 17 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations WEIGHT LOSS	8.6% 8/93 • Number of events 8 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Respiratory, thoracic and mediastinal disorders WHEEZING	8.6% 8/93 • Number of events 10 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Investigations WHITE BLOOD CELL DECREASED	7.5% 7/93 • Number of events 8 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.
Injury, poisoning and procedural complications WRIST FRACTURE	1.1% 1/93 • Number of events 1 • Adverse Events were assessed from the time of consent until 30 days after last dose of Pembrolizumab up to a maximum of 18 months. All-Cause mortality was assessed from the date of randomization up to a maximum of 47 months or death. Adverse events were collected for every subject at every cycle of treatment (18 cycles) at an interval of 21 days from the time of consent until 30 days after last dose of Pembrolizumab.Serious adverse events and the concomitant medications used to treat them were collected up to 90 days post treatment.

Additional Information

Annesha Majumdar

Hoosier Cancer Research Network

Phone: 3179212050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place