Trial Outcomes & Findings for A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy (NCT NCT03522246)

Last Updated: 2025-06-24

Results Overview

PFS by investigator was defined as the time from randomization to disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

1097 participants

Primary outcome timeframe

From randomization until disease progression (up to the primary data analysis at approximately 39 months)

Results posted on

2025-06-24

Participant Flow

Enrollment is complete and the study is ongoing. Data are presented here for the primary endpoint analysis.

Participant milestones

Participant milestones
Measure	Arm A: Rucaparib + Nivolumab Participants received oral rucaparib tablets twice daily and nivolumab intravenous (IV) infusion once every 4 weeks.	Arm B: Rucaparib + Placebo Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm C: Placebo + Nivolumab Participants received oral placebo tablets twice daily and nivolumab IV infusion once every 4 weeks.	Arm D: Placebo + Placebo Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.	Japanese Open-label Safety Cohort: Rucaparib + Nivolumab Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.
Overall Study STARTED	436	427	108	111	15
Overall Study Received at Least 1 Dose of Study Drug	433	425	108	110	15
Overall Study Safety Population	410	448	107	111	15
Overall Study COMPLETED	252	233	62	66	15
Overall Study NOT COMPLETED	184	194	46	45	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Rucaparib + Nivolumab Participants received oral rucaparib tablets twice daily and nivolumab intravenous (IV) infusion once every 4 weeks.	Arm B: Rucaparib + Placebo Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm C: Placebo + Nivolumab Participants received oral placebo tablets twice daily and nivolumab IV infusion once every 4 weeks.	Arm D: Placebo + Placebo Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.	Japanese Open-label Safety Cohort: Rucaparib + Nivolumab Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.
Overall Study Ongoing in Long-Term Follow-up (Alive)	184	194	46	45	0

Baseline Characteristics

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Rucaparib + Nivolumab n=436 Participants Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.	Arm B: Rucaparib + Placebo n=427 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm C: Placebo + Nivolumab n=108 Participants Participants received oral placebo tablets twice daily and nivolumab IV infusion once every 4 weeks	Arm D: Placebo + Placebo n=111 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.	Japanese Open-label Safety Cohort: Rucaparib + Nivolumab n=15 Participants Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.	Total n=1097 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	281 Participants n=5 Participants	270 Participants n=7 Participants	72 Participants n=5 Participants	68 Participants n=4 Participants	13 Participants n=21 Participants	704 Participants n=8 Participants
Age, Categorical >=65 years	155 Participants n=5 Participants	157 Participants n=7 Participants	36 Participants n=5 Participants	43 Participants n=4 Participants	2 Participants n=21 Participants	393 Participants n=8 Participants
Sex: Female, Male Female	436 Participants n=5 Participants	427 Participants n=7 Participants	108 Participants n=5 Participants	111 Participants n=4 Participants	15 Participants n=21 Participants	1097 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	17 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	34 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	405 Participants n=5 Participants	397 Participants n=7 Participants	102 Participants n=5 Participants	107 Participants n=4 Participants	14 Participants n=21 Participants	1025 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	13 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	38 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 Participants
Race (NIH/OMB) Asian	81 Participants n=5 Participants	80 Participants n=7 Participants	22 Participants n=5 Participants	16 Participants n=4 Participants	15 Participants n=21 Participants	214 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	17 Participants n=8 Participants
Race (NIH/OMB) White	325 Participants n=5 Participants	328 Participants n=7 Participants	83 Participants n=5 Participants	87 Participants n=4 Participants	0 Participants n=21 Participants	823 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	31 Participants n=8 Participants

PRIMARY outcome

Timeframe: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

Population: The homologous recombination deficiency (HRD) population consisted of all randomized participants with either a tumor tissue alteration in breast cancer genes (BRCA)1 or BRCA2 (tBRCA) or non-tBRCA high loss of heterozygosity (LOHhigh). Presented here are data for the monotherapy comparison arms (Arm B and Arm D).

Outcome measures

Outcome measures
Measure	Arm B: Rucaparib + Placebo n=185 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=49 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
Monotherapy Arm B and Arm D: Investigator Assessed Progression-free Survival (PFS)	28.7 months Interval 23.0 to Not reached due to insufficient number of events	11.3 months Interval 9.1 to 22.1

PRIMARY outcome

Timeframe: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

Population: The ITT population included all randomized participants. Presented here are data for the monotherapy comparison arms (Arm B and Arm D).

PFS by investigator was defined as the time from randomization to disease progression, according to RECIST v1.1 as assessed by the investigator, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Outcome measures

Outcome measures
Measure	Arm B: Rucaparib + Placebo n=427 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=111 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
Monotherapy Arm B and Arm D: Investigator Assessed PFS	20.2 months Interval 15.2 to 24.7	9.2 months Interval 8.3 to 12.2

PRIMARY outcome

Timeframe: From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

Population: The ITT population included all randomized participants. Presented here are data from combination comparison arms (Arm A and Arm B).

Outcome measures

Outcome measures
Measure	Arm B: Rucaparib + Placebo n=436 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=427 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
Combination Therapy Arm A and Arm B: Investigator Assessed PFS	15.0 months Interval 12.1 to 17.4	20.2 months Interval 15.6 to 24.0

SECONDARY outcome

Timeframe: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

Population: The HRD population consisted of all randomized participants with either tBRCA or non-tBRCA LOHhigh. Presented here are data from the monotherapy comparison arms (Arm B and Arm D).

PFS was assessed by BICR per RECIST v1.1 as the time from randomization to disease progression, or death due to any cause, whichever occurred first. Progressive disease was defined as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Outcome measures

Outcome measures
Measure	Arm B: Rucaparib + Placebo n=185 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=49 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
Monotherapy Arm B and Arm D: Blinded Independent Central Review (BICR) PFS	NA months Interval 28.7 to Not reached due to insufficient number of events	9.9 months Interval 6.5 to Not reached due to insufficient number of events

SECONDARY outcome

Timeframe: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

Population: The ITT population included all randomized participants. Presented here are data from the monotherapy comparison arms (Arm B and Arm D).

Outcome measures

Outcome measures
Measure	Arm B: Rucaparib + Placebo n=427 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=111 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
Monotherapy Arm B and Arm D: BICR PFS	25.9 months Interval 16.8 to Not reached due to insufficient number of events	9.1 months Interval 6.4 to 9.7

SECONDARY outcome

Timeframe: From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

Population: BICR was included as a supportive secondary endpoint in the event that the Investigator-assessed PFS result was positive. In the ATHENA-COMBO statistical analysis plan it was specified that the BICR analysis would only be performed if the primary endpoint of Investigator-assessed PFS was statistically significant. Given that the result was negative and not statistically significant, the analysis of BICR was not performed, thus that data is not available and cannot be provided.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization until death due to any cause (up to the primary data analysis at approximately 36 months)

Population: The HRD population consisted of all randomized participants with either tBRCA or non-tBRCA LOHhigh. Presented here are data from the monotherapy comparison arms (Arm B and Arm D).

OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Arm B: Rucaparib + Placebo n=185 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=49 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
Monotherapy Arm B and Arm D: Overall Survival (OS)	NA months Not reached due to insufficient number of events.	NA months Not reached due to insufficient number of events.

SECONDARY outcome

Timeframe: From randomization until death due to any cause (up to the primary data analysis at approximately 40 months)

Population: The ITT population included all randomized participants. Presented here are data from the monotherapy comparison arms (Arm B and Arm D).

OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Arm B: Rucaparib + Placebo n=427 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=111 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
Monotherapy Arm B and Arm D: OS	38.8 months Interval 38.8 to Not reached due to insufficient number of events.	NA months Interval 31.4 to Not reached due to insufficient number of events.

SECONDARY outcome

Timeframe: From randomization until death due to any cause (up to the combination therapy interim analysis at approximately 72 months)

Population: The ITT population included all randomized participants. Presented here are data from combination comparison arms (Arm A and Arm B).

OS was defined as the number of days (measured in months) from the date of randomization to the date of death due to any cause.

Outcome measures

Outcome measures
Measure	Arm B: Rucaparib + Placebo n=436 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=427 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
Combination Therapy Arm A and Arm B: OS	49.4 months Interval 43.9 to 55.3	58.0 months Interval 46.7 to Not reached due to insufficient number of events

SECONDARY outcome

Timeframe: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

Population: The HRD population consisted of all randomized participants with either tBRCA or non-tBRCA LOHhigh. Presented here are data from the monotherapy comparison arms (Arm B and Arm D). Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure with measurable disease at baseline.

ORR was defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Arm B: Rucaparib + Placebo n=17 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=5 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
Monotherapy Arm B and Arm D: Objective Response Rate (ORR)	58.8 percentage of participants Interval 32.9 to 81.6	20.0 percentage of participants Interval 0.5 to 71.6

SECONDARY outcome

Timeframe: From randomization until disease progression (up to the primary data analysis at approximately 39 months)

Population: The ITT population included all randomized participants. Presented here are data from the monotherapy comparison arms (Arm B and Arm D). Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure with measurable disease at baseline.

ORR was defined as the percentage of participants with CR or PR as assessed by the Investigator per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Arm B: Rucaparib + Placebo n=41 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=11 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
Monotherapy Arm B and Arm D: ORR	48.8 percentage of participants Interval 32.9 to 64.9	9.1 percentage of participants Interval 0.2 to 41.3

SECONDARY outcome

Timeframe: From randomization until disease progression (up to the combination therapy interim analysis at approximately 66 months)

Population: The ITT population included all randomized participants. Presented here are data from combination comparison arms (Arm A and Arm B). Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure with measurable disease at baseline.

Outcome measures

Outcome measures
Measure	Arm B: Rucaparib + Placebo n=39 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=41 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
Combination Therapy Arm A and Arm B: ORR	25.6 percentage of participants Interval 13.0 to 42.1	48.8 percentage of participants Interval 32.9 to 64.9

SECONDARY outcome

Timeframe: From first confirmed response until disease progression (up to the primary data analysis at approximately 30 months)

DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of progressive disease (PD) or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Outcome measures

Outcome measures
Measure	Arm B: Rucaparib + Placebo n=10 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=1 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
Monotherapy Arm B and Arm D: Duration of Response (DOR)	16.7 months Interval 5.7 to Not reached due to insufficient number of events	5.5 months Not reached due to insufficient number of events

SECONDARY outcome

Timeframe: From first confirmed response until disease progression (up to the primary data analysis at approximately 33 months)

DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of PD or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Outcome measures

Outcome measures
Measure	Arm B: Rucaparib + Placebo n=20 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=1 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
Monotherapy Arm B and Arm D: DOR	22.1 months Interval 8.4 to Not reached due to insufficient number of events	5.5 months Not reached due to insufficient number of events

SECONDARY outcome

Timeframe: From first confirmed response until disease progression (up to the combination therapy interim analysis at approximately 60 months)

Population: The ITT population included all randomized participants. Presented here are data from the combination comparison arms (Arm A and Arm B). Here, "Overall Number of Participants Analyzed" is the number of participants evaluable for this outcome measure with measurable disease at baseline.

DOR was assessed by the investigator and defined as the interval from the first documentation of objective response (CR or PR per RECIST v1.1) to the earlier of the first documentation of PD or death from any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Outcome measures

Outcome measures
Measure	Arm B: Rucaparib + Placebo n=10 Participants Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=20 Participants Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.
Combination Therapy Arm A and Arm B: DOR	13.7 months Interval 5.6 to Not reached due to insufficient number of events	27.7 months Interval 8.4 to Not reached due to insufficient number of events

Adverse Events

Arm A: Rucaparib + Nivolumab

Serious events: 154 serious events

Other events: 406 other events

Deaths: 12 deaths

Arm B: Rucaparib + Placebo

Serious events: 117 serious events

Other events: 433 other events

Deaths: 20 deaths

Arm C: Placebo + Nivolumab

Serious events: 18 serious events

Other events: 99 other events

Deaths: 4 deaths

Arm D: Placebo + Placebo

Serious events: 13 serious events

Other events: 103 other events

Deaths: 2 deaths

Japanese Open-label Safety Cohort: Rucaparib + Nivolumab

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: Rucaparib + Nivolumab n=410 participants at risk Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.	Arm B: Rucaparib + Placebo n=448 participants at risk Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm C: Placebo + Nivolumab n=107 participants at risk Participants received oral placebo tablets twice daily and nivolumab IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=111 participants at risk Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.	Japanese Open-label Safety Cohort: Rucaparib + Nivolumab n=15 participants at risk Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.
Blood and lymphatic system disorders Anaemia	5.6% 23/410 • Number of events 35 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.0% 18/448 • Number of events 20 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Blood and lymphatic system disorders Febrile neutropenia	7.3% 30/410 • Number of events 37 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.67% 3/448 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Blood and lymphatic system disorders Haemolytic anaemia	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Blood and lymphatic system disorders Leukopenia	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Blood and lymphatic system disorders Lymphadenopathy	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Blood and lymphatic system disorders Neutropenia	0.98% 4/410 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.3% 6/448 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Blood and lymphatic system disorders Pancytopenia	2.4% 10/410 • Number of events 10 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.67% 3/448 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Blood and lymphatic system disorders Thrombocytopenia	0.98% 4/410 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.89% 4/448 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Cardiac disorders Acute coronary syndrome	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Cardiac disorders Acute left ventricular failure	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Cardiac disorders Atrial fibrillation	0.73% 3/410 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Cardiac disorders Cardiac arrest	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Cardiac disorders Cardio-respiratory arrest	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Cardiac disorders Myocardial infarction	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Cardiac disorders Ventricular tachycardia	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Endocrine disorders Adrenal insufficiency	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Endocrine disorders Hypophysitis	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Endocrine disorders Hypopituitarism	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Endocrine disorders Hypothyroidism	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Eye disorders Age-related macular degeneration	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Eye disorders Cataract	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Eye disorders Iritis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Eye disorders Uveitis	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Eye disorders Vogt-Koyanagi-Harada disease	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Abdominal adhesions	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Abdominal hernia obstructive	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Abdominal pain	1.2% 5/410 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.1% 5/448 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Anal fissure	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Appendix disorder	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Ascites	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Autoimmune colitis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Colitis	0.73% 3/410 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Diaphragmatic hernia	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Diarrhoea	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Enteritis	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Enterocolitis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Hepatobiliary disorders Hepatic failure	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Ileus	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.67% 3/448 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.8% 2/111 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Immune-mediated enterocolitis	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Intestinal obstruction	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.67% 3/448 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Intestinal perforation	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Large intestinal obstruction	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Megacolon	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Nausea	0.73% 3/410 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Neutropenic colitis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Oesophagitis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Pancreatitis acute	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Small intestinal obstruction	2.7% 11/410 • Number of events 14 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.1% 5/448 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Vomiting	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.89% 4/448 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
General disorders Asthenia	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
General disorders Fatigue	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
General disorders Multiple organ dysfunction syndrome	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
General disorders Pyrexia	2.0% 8/410 • Number of events 10 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.45% 2/448 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Hepatobiliary disorders Autoimmune hepatitis	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Hepatobiliary disorders Cholecystitis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Hepatobiliary disorders Cholecystitis acute	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Hepatobiliary disorders Cholecystitis chronic	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Hepatobiliary disorders Cholelithiasis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Hepatobiliary disorders Drug-induced liver injury	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Hepatobiliary disorders Hepatic function abnormal	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Hepatobiliary disorders Hepatitis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Hepatobiliary disorders Hypertransaminasaemia	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Immune system disorders Drug hypersensitivity	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Appendicitis	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Atypical pneumonia	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Bacteraemia	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Brucellosis	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations COVID-19	0.73% 3/410 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.67% 3/448 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations COVID-19 pneumonia	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.45% 2/448 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Catheter site infection	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Clostridium difficile colitis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Clostridium difficile infection	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Cystitis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Cytomegalovirus infection	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Device related infection	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Diverticulitis	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Encephalitis	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Enterocolitis infectious	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Infected lymphocele	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.45% 2/448 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Influenza	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Klebsiella infection	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Lower respiratory tract infection	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Meningitis	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Neutropenic sepsis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Pneumonia	1.2% 5/410 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.89% 4/448 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Pulmonary tuberculosis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Pyelonephritis	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.45% 2/448 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Pyelonephritis acute	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Sepsis	0.73% 3/410 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.45% 2/448 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Skin infection	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Staphylococcal sepsis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Upper respiratory tract infection	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Urinary tract infection	1.5% 6/410 • Number of events 7 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.3% 6/448 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Urosepsis	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Vaginal infection	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Viral infection	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Ankle fracture	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Fall	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Hip fracture	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Infusion related reaction	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Product administration error	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Radius fracture	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Stoma prolapse	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Alanine aminotransferase increased	2.0% 8/410 • Number of events 9 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.45% 2/448 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Aspartate aminotransferase increased	1.5% 6/410 • Number of events 7 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.45% 2/448 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Blood alkaline phosphatase increased	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Blood bilirubin increased	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Blood creatine phosphokinase increased	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Blood creatinine increased	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations C-reactive protein increased	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Liver function test increased	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Neutrophil count decreased	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Platelet count decreased	0.73% 3/410 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Decreased appetite	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Dehydration	0.49% 2/410 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Diabetic ketoacidosis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Electrolyte imbalance	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Hyperglycaemia	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Hyperkalaemia	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Hyponatraemia	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.45% 2/448 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Musculoskeletal and connective tissue disorders Back pain	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Musculoskeletal and connective tissue disorders Muscular weakness	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Musculoskeletal and connective tissue disorders Myalgia	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Musculoskeletal and connective tissue disorders Seronegative arthritis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.73% 3/410 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	3.6% 16/448 • Number of events 16 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.8% 3/107 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nodular melanoma	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neuroendocrine tumour	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Bell's palsy	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Brain oedema	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Cerebral haemorrhage	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Cerebrovascular accident	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Encephalopathy	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Headache	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Myasthenia gravis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Paraneoplastic neurological syndrome	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Syncope	0.73% 3/410 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Psychiatric disorders Delirium	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Renal and urinary disorders Acute kidney injury	1.5% 6/410 • Number of events 7 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.45% 2/448 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Renal and urinary disorders Hydronephrosis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Renal and urinary disorders Renal impairment	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Reproductive system and breast disorders Vaginal haemorrhage	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.98% 4/410 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.67% 3/448 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Respiratory, thoracic and mediastinal disorders Non-cardiogenic pulmonary oedema	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.67% 3/448 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.2% 5/410 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Drug eruption	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Rash	0.73% 3/410 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Rash morbilliform	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Vascular disorders Deep vein thrombosis	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Vascular disorders Embolism	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Vascular disorders Haematoma	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Vascular disorders Hypertension	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Vascular disorders Peripheral arterial occlusive disease	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).

Other adverse events

Other adverse events
Measure	Arm A: Rucaparib + Nivolumab n=410 participants at risk Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.	Arm B: Rucaparib + Placebo n=448 participants at risk Participants received oral rucaparib tablets twice daily and placebo IV infusion once every 4 weeks.	Arm C: Placebo + Nivolumab n=107 participants at risk Participants received oral placebo tablets twice daily and nivolumab IV infusion once every 4 weeks.	Arm D: Placebo + Placebo n=111 participants at risk Participants received oral placebo tablets twice daily and placebo IV infusion once every 4 weeks.	Japanese Open-label Safety Cohort: Rucaparib + Nivolumab n=15 participants at risk Participants received oral rucaparib tablets twice daily and nivolumab IV infusion once every 4 weeks.
Infections and infestations Upper respiratory tract infection	8.0% 33/410 • Number of events 41 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	5.4% 24/448 • Number of events 30 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.5% 8/107 • Number of events 9 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.8% 2/111 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Urinary tract infection	12.7% 52/410 • Number of events 80 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	9.2% 41/448 • Number of events 53 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	11.2% 12/107 • Number of events 20 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	10.8% 12/111 • Number of events 19 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Blood and lymphatic system disorders Anaemia	48.3% 198/410 • Number of events 789 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	44.2% 198/448 • Number of events 778 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	9.3% 10/107 • Number of events 23 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	9.9% 11/111 • Number of events 23 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	80.0% 12/15 • Number of events 49 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Blood and lymphatic system disorders Leukopenia	9.8% 40/410 • Number of events 118 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.0% 18/448 • Number of events 69 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.7% 3/111 • Number of events 8 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	26.7% 4/15 • Number of events 7 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Blood and lymphatic system disorders Lymphopenia	2.9% 12/410 • Number of events 21 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.0% 9/448 • Number of events 20 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.3% 2/15 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Blood and lymphatic system disorders Neutropenia	21.7% 89/410 • Number of events 300 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	14.5% 65/448 • Number of events 216 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.7% 5/107 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.2% 8/111 • Number of events 18 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	40.0% 6/15 • Number of events 20 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Blood and lymphatic system disorders Thrombocytopenia	19.0% 78/410 • Number of events 198 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	11.4% 51/448 • Number of events 126 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Ear and labyrinth disorders Deafness	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Ear and labyrinth disorders Vertigo	2.0% 8/410 • Number of events 9 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.3% 6/448 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Endocrine disorders Adrenal insufficiency	0.73% 3/410 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Endocrine disorders Hyperthyroidism	6.3% 26/410 • Number of events 33 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.67% 3/448 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	10.3% 11/107 • Number of events 12 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.7% 3/111 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Endocrine disorders Hypothyroidism	9.8% 40/410 • Number of events 57 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.7% 12/448 • Number of events 14 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.1% 14/107 • Number of events 19 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.5% 5/111 • Number of events 7 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Endocrine disorders Thyroiditis	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Eye disorders Eye disorder	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Eye disorders Uveitis	3.7% 15/410 • Number of events 24 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	26.7% 4/15 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Eye disorders Vitreous floaters	0.98% 4/410 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Abdominal distension	8.0% 33/410 • Number of events 40 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	9.8% 44/448 • Number of events 56 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.8% 3/107 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.5% 15/111 • Number of events 17 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Abdominal pain	22.2% 91/410 • Number of events 139 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	24.3% 109/448 • Number of events 146 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	14.0% 15/107 • Number of events 21 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	28.8% 32/111 • Number of events 45 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	26.7% 4/15 • Number of events 8 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Abdominal pain upper	8.5% 35/410 • Number of events 46 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	9.4% 42/448 • Number of events 55 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.7% 5/107 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	8.1% 9/111 • Number of events 15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Anal fistula	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Cheilitis	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Constipation	24.4% 100/410 • Number of events 137 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	19.0% 85/448 • Number of events 125 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	10.3% 11/107 • Number of events 12 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	15.3% 17/111 • Number of events 20 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Dental caries	0.73% 3/410 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.67% 3/448 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Diarrhoea	27.6% 113/410 • Number of events 217 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	23.9% 107/448 • Number of events 181 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	18.7% 20/107 • Number of events 34 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	22.5% 25/111 • Number of events 41 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.3% 2/15 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Dry mouth	4.9% 20/410 • Number of events 22 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	3.6% 16/448 • Number of events 16 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.5% 7/107 • Number of events 11 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.5% 5/111 • Number of events 7 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Duodenal ulcer	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Dyspepsia	7.3% 30/410 • Number of events 38 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	9.8% 44/448 • Number of events 55 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.7% 5/107 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	8.1% 9/111 • Number of events 11 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Gastrooesophageal reflux disease	3.7% 15/410 • Number of events 18 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.7% 21/448 • Number of events 23 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.7% 5/107 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	3.6% 4/111 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Haemorrhoids	1.7% 7/410 • Number of events 7 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.6% 7/448 • Number of events 7 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.8% 2/111 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.3% 2/15 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Nausea	57.1% 234/410 • Number of events 458 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	56.7% 254/448 • Number of events 457 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	25.2% 27/107 • Number of events 32 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	30.6% 34/111 • Number of events 52 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	66.7% 10/15 • Number of events 24 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Stomatitis	9.3% 38/410 • Number of events 59 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.6% 34/448 • Number of events 72 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.5% 7/107 • Number of events 10 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	3.6% 4/111 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	26.7% 4/15 • Number of events 8 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Gastrointestinal disorders Vomiting	31.2% 128/410 • Number of events 226 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	23.9% 107/448 • Number of events 187 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	10.3% 11/107 • Number of events 16 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	12.6% 14/111 • Number of events 17 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	26.7% 4/15 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
General disorders Asthenia	13.7% 56/410 • Number of events 117 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.8% 62/448 • Number of events 114 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.5% 7/107 • Number of events 11 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	10.8% 12/111 • Number of events 17 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
General disorders Fatigue	45.4% 186/410 • Number of events 384 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	42.2% 189/448 • Number of events 344 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	22.4% 24/107 • Number of events 36 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	30.6% 34/111 • Number of events 56 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	33.3% 5/15 • Number of events 13 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
General disorders Malaise	3.7% 15/410 • Number of events 23 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.9% 13/448 • Number of events 24 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	20.0% 3/15 • Number of events 7 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
General disorders Non-cardiac chest pain	1.2% 5/410 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.8% 2/111 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
General disorders Oedema	2.4% 10/410 • Number of events 11 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.1% 5/448 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	3.7% 4/107 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
General disorders Oedema peripheral	7.8% 32/410 • Number of events 45 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.6% 34/448 • Number of events 45 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	3.7% 4/107 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	11.7% 13/111 • Number of events 15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
General disorders Pyrexia	15.9% 65/410 • Number of events 97 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	9.2% 41/448 • Number of events 51 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	8.4% 9/107 • Number of events 9 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	5.4% 6/111 • Number of events 9 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	20.0% 3/15 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Acarodermatitis	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations COVID-19	7.3% 30/410 • Number of events 34 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.0% 27/448 • Number of events 29 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.8% 3/107 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Cystitis	1.7% 7/410 • Number of events 9 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.7% 12/448 • Number of events 13 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.5% 5/111 • Number of events 8 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Hordeolum	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.67% 3/448 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Influenza	1.2% 5/410 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.45% 2/448 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.8% 2/111 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Nasopharyngitis	3.9% 16/410 • Number of events 21 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.9% 22/448 • Number of events 36 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.8% 2/111 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	26.7% 4/15 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Papilloma viral infection	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Paronychia	0.49% 2/410 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.8% 3/107 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Infections and infestations Subcutaneous abscess	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Rib fracture	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Injury, poisoning and procedural complications Skin abrasion	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Alanine aminotransferase increased	51.7% 212/410 • Number of events 614 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	39.7% 178/448 • Number of events 464 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	15.9% 17/107 • Number of events 28 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.2% 8/111 • Number of events 16 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	80.0% 12/15 • Number of events 57 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Amylase increased	0.49% 2/410 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/448 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.8% 2/111 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Aspartate aminotransferase increased	48.0% 197/410 • Number of events 452 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	35.9% 161/448 • Number of events 341 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	14.0% 15/107 • Number of events 26 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	8.1% 9/111 • Number of events 13 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	93.3% 14/15 • Number of events 39 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Blood alkaline phosphatase increased	10.0% 41/410 • Number of events 69 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	9.4% 42/448 • Number of events 56 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.8% 2/111 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	26.7% 4/15 • Number of events 12 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Blood bilirubin increased	7.6% 31/410 • Number of events 80 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.2% 19/448 • Number of events 40 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.8% 2/111 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Blood cholesterol increased	7.3% 30/410 • Number of events 48 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.0% 27/448 • Number of events 69 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.7% 5/107 • Number of events 12 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.7% 3/111 • Number of events 7 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Blood creatinine increased	16.1% 66/410 • Number of events 162 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	11.6% 52/448 • Number of events 108 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.5% 7/107 • Number of events 8 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	5.4% 6/111 • Number of events 11 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	26.7% 4/15 • Number of events 9 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Gamma-glutamyltransferase increased	2.2% 9/410 • Number of events 14 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.0% 9/448 • Number of events 15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.3% 2/15 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Lymphocyte count decreased	4.4% 18/410 • Number of events 33 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.7% 12/448 • Number of events 26 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Neutrophil count decreased	16.8% 69/410 • Number of events 309 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.6% 61/448 • Number of events 223 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	5.6% 6/107 • Number of events 15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	40.0% 6/15 • Number of events 13 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations Platelet count decreased	15.9% 65/410 • Number of events 240 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.2% 59/448 • Number of events 185 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 7 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	60.0% 9/15 • Number of events 64 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Investigations White blood cell count decreased	14.1% 58/410 • Number of events 217 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	8.9% 40/448 • Number of events 135 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.7% 3/111 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	46.7% 7/15 • Number of events 29 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Decreased appetite	19.5% 80/410 • Number of events 126 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	17.9% 80/448 • Number of events 111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.5% 7/107 • Number of events 13 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	16.2% 18/111 • Number of events 20 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Dyslipidaemia	0.98% 4/410 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.3% 2/15 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Hypercholesterolaemia	3.4% 14/410 • Number of events 28 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	5.8% 26/448 • Number of events 52 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.7% 5/107 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.3% 7/111 • Number of events 10 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Hyperglycaemia	4.6% 19/410 • Number of events 28 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.7% 21/448 • Number of events 29 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.3% 7/111 • Number of events 12 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Hypokalaemia	7.3% 30/410 • Number of events 39 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	5.1% 23/448 • Number of events 34 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.8% 2/111 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Hypomagnesaemia	6.1% 25/410 • Number of events 47 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.1% 32/448 • Number of events 52 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	3.7% 4/107 • Number of events 10 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.8% 2/111 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Metabolism and nutrition disorders Hyponatraemia	4.6% 19/410 • Number of events 34 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	3.1% 14/448 • Number of events 36 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.3% 7/111 • Number of events 9 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Musculoskeletal and connective tissue disorders Arthralgia	24.1% 99/410 • Number of events 162 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	20.5% 92/448 • Number of events 142 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	22.4% 24/107 • Number of events 42 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	22.5% 25/111 • Number of events 36 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.3% 2/15 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Musculoskeletal and connective tissue disorders Arthritis	1.5% 6/410 • Number of events 8 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.2% 10/448 • Number of events 11 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Musculoskeletal and connective tissue disorders Back pain	12.9% 53/410 • Number of events 70 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	10.0% 45/448 • Number of events 62 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	10.3% 11/107 • Number of events 11 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.5% 15/111 • Number of events 25 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Musculoskeletal and connective tissue disorders Flank pain	1.2% 5/410 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.0% 9/448 • Number of events 11 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	5.4% 6/111 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Musculoskeletal and connective tissue disorders Muscular weakness	3.7% 15/410 • Number of events 22 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.9% 13/448 • Number of events 17 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.8% 3/107 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.2% 8/111 • Number of events 13 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Musculoskeletal and connective tissue disorders Myalgia	9.0% 37/410 • Number of events 59 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	12.1% 54/448 • Number of events 76 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.8% 3/107 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	9.0% 10/111 • Number of events 14 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Musculoskeletal and connective tissue disorders Pain in extremity	6.6% 27/410 • Number of events 38 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	8.9% 40/448 • Number of events 55 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	3.7% 4/107 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.2% 8/111 • Number of events 16 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Disturbance in attention	0.73% 3/410 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.89% 4/448 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Dizziness	15.9% 65/410 • Number of events 82 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.2% 59/448 • Number of events 81 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	11.2% 12/107 • Number of events 13 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	9.9% 11/111 • Number of events 14 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Dysgeusia	19.8% 81/410 • Number of events 100 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	20.3% 91/448 • Number of events 125 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.5% 7/107 • Number of events 8 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	5.4% 6/111 • Number of events 8 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	53.3% 8/15 • Number of events 14 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Headache	19.0% 78/410 • Number of events 127 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	19.6% 88/448 • Number of events 151 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	8.4% 9/107 • Number of events 10 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	16.2% 18/111 • Number of events 35 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.3% 2/15 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Hypoaesthesia	2.2% 9/410 • Number of events 11 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.5% 11/448 • Number of events 11 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.8% 2/111 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Neuropathy peripheral	5.9% 24/410 • Number of events 35 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	8.3% 37/448 • Number of events 45 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.5% 8/107 • Number of events 14 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.3% 7/111 • Number of events 9 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Restless legs syndrome	0.24% 1/410 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.3% 6/448 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Somnolence	1.5% 6/410 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.45% 2/448 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Nervous system disorders Taste disorder	5.1% 21/410 • Number of events 25 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	5.4% 24/448 • Number of events 24 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Psychiatric disorders Anxiety	6.1% 25/410 • Number of events 28 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.5% 20/448 • Number of events 24 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.7% 3/111 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Psychiatric disorders Depression	4.4% 18/410 • Number of events 21 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.0% 18/448 • Number of events 20 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	5.6% 6/107 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.8% 2/111 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Psychiatric disorders Insomnia	13.7% 56/410 • Number of events 63 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.8% 62/448 • Number of events 84 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.5% 8/107 • Number of events 9 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.2% 8/111 • Number of events 9 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Respiratory, thoracic and mediastinal disorders Cough	13.4% 55/410 • Number of events 75 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	12.5% 56/448 • Number of events 75 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	5.6% 6/107 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	9.9% 11/111 • Number of events 15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.3% 67/410 • Number of events 106 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	11.4% 51/448 • Number of events 78 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	12.1% 13/107 • Number of events 14 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	11.7% 13/111 • Number of events 16 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.1% 25/410 • Number of events 29 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.9% 13/448 • Number of events 19 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	3.7% 4/107 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	3.6% 4/111 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Alopecia	2.2% 9/410 • Number of events 10 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	3.1% 14/448 • Number of events 14 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.7% 3/111 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.98% 4/410 • Number of events 7 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.67% 3/448 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Dry skin	5.4% 22/410 • Number of events 31 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	5.1% 23/448 • Number of events 31 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	4.7% 5/107 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.8% 2/111 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Nail discolouration	0.49% 2/410 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Photosensitivity reaction	6.3% 26/410 • Number of events 40 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.9% 31/448 • Number of events 35 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Pigmentation disorder	0.00% 0/410 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.22% 1/448 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/107 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/111 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Pruritus	18.5% 76/410 • Number of events 119 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	15.8% 71/448 • Number of events 106 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.5% 8/107 • Number of events 8 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	10.8% 12/111 • Number of events 13 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Rash	17.6% 72/410 • Number of events 121 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	14.5% 65/448 • Number of events 95 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	15.9% 17/107 • Number of events 32 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.2% 8/111 • Number of events 11 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	26.7% 4/15 • Number of events 7 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Skin and subcutaneous tissue disorders Rash maculo-papular	9.0% 37/410 • Number of events 74 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.6% 7/448 • Number of events 12 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 5 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	3.6% 4/111 • Number of events 6 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	13.3% 2/15 • Number of events 3 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Vascular disorders Hot flush	3.7% 15/410 • Number of events 17 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.1% 32/448 • Number of events 38 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	1.9% 2/107 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	2.7% 3/111 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Vascular disorders Hypertension	6.3% 26/410 • Number of events 39 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	5.8% 26/448 • Number of events 46 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	3.7% 4/107 • Number of events 12 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	7.2% 8/111 • Number of events 15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.00% 0/15 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).
Vascular disorders Lymphoedema	0.49% 2/410 • Number of events 4 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.45% 2/448 • Number of events 2 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.93% 1/107 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	0.90% 1/111 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).	6.7% 1/15 • Number of events 1 • Up to approximately 5 years The Safety Population consisted of all participants who received at least 1 dose of protocol-specified treatment (oral and/or IV study drug). For safety analyses, data were presented separately for all treatment arms according to actual treatment given, such that participants randomized to either treatment group containing IV nivolumab (ie, Arms A or C) who never received nivolumab were then analyzed in the analogous treatment group that contained IV placebo (ie, Arms B or D, respectively).

Additional Information

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Principal investigator is a sponsor employee Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
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