Trial Outcomes & Findings for An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer (NCT NCT02743494)

Last Updated: 2025-11-18

Results Overview

Disease-free survival is defined as the time between randomization date and first date of recurrence or death, whichever occurs first. Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. For participants who remained alive and without recurrence, DFS was censured on the date of last evaluable disease assessment

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

794 participants

Primary outcome timeframe

From randomization to the date of recurrence or death (up to approximately 46 months)

Results posted on

2025-11-18

Participant Flow

794 participants were randomized and 792 were treated. The reasons for the 2 participants not being treated were: Participant request to discontinue study treatment (1) and Participant no longer meeting study criteria (1).

Participant milestones

Participant milestones
Measure	Nivolumab Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.	Placebo Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
Pre-treatment Period STARTED	532	262
Pre-treatment Period COMPLETED	532	260
Pre-treatment Period NOT COMPLETED	0	2
Treatment Period STARTED	532	260
Treatment Period COMPLETED	260	116
Treatment Period NOT COMPLETED	272	144

Reasons for withdrawal

Reasons for withdrawal
Measure	Nivolumab Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.	Placebo Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
Pre-treatment Period Participant request to discontinue treatment	0	1
Pre-treatment Period Participant no longer meeting study criteria	0	1
Treatment Period Disease recurrence	152	115
Treatment Period Study drug toxicity	56	8
Treatment Period Death	1	1
Treatment Period Adverse event unrelated to study drug	15	9
Treatment Period Participant request to discontinue treatment	31	5
Treatment Period Participant withdrew consent	11	4
Treatment Period Lost to Follow-up	0	1
Treatment Period Poor/Non-compliance	2	0
Treatment Period Other reasons	4	1

Baseline Characteristics

An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nivolumab n=532 Participants Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.	Placebo n=262 Participants Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles	Total n=794 Participants Total of all reporting groups
Age, Continuous	60.8 Years STANDARD_DEVIATION 9.2 • n=202 Participants	59.9 Years STANDARD_DEVIATION 10.1 • n=283 Participants	60.5 Years STANDARD_DEVIATION 9.5 • n=120 Participants
Sex: Female, Male Female	83 Participants n=202 Participants	40 Participants n=283 Participants	123 Participants n=120 Participants
Sex: Female, Male Male	449 Participants n=202 Participants	222 Participants n=283 Participants	671 Participants n=120 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=202 Participants	11 Participants n=283 Participants	44 Participants n=120 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	268 Participants n=202 Participants	144 Participants n=283 Participants	412 Participants n=120 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	231 Participants n=202 Participants	107 Participants n=283 Participants	338 Participants n=120 Participants
Race/Ethnicity, Customized White	432 Participants n=202 Participants	216 Participants n=283 Participants	648 Participants n=120 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=202 Participants	2 Participants n=283 Participants	9 Participants n=120 Participants
Race/Ethnicity, Customized Asian	83 Participants n=202 Participants	34 Participants n=283 Participants	117 Participants n=120 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=202 Participants	2 Participants n=283 Participants	2 Participants n=120 Participants
Race/Ethnicity, Customized Other	10 Participants n=202 Participants	7 Participants n=283 Participants	17 Participants n=120 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=202 Participants	1 Participants n=283 Participants	1 Participants n=120 Participants

PRIMARY outcome

Timeframe: From randomization to the date of recurrence or death (up to approximately 46 months)

Population: All randomized participants

Outcome measures

Outcome measures
Measure	Nivolumab n=532 Participants Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.	Placebo n=262 Participants Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
Disease-free Survival (DFS)	22.41 Months Interval 16.62 to 34.0	11.04 Months Interval 8.34 to 14.32

SECONDARY outcome

Timeframe: From randomization to the date of death (up to approximately 60 months)

Population: All randomized participants.

Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date"). Overall survival was censored at the date of randomization for subjects who were randomized but had no follow-up.

Outcome measures

Outcome measures
Measure	Nivolumab n=532 Participants Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.	Placebo n=262 Participants Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
Overall Survival (OS)	51.71 Months Interval 41.03 to 61.63	35.25 Months Interval 30.72 to 48.76

SECONDARY outcome

Timeframe: At 12-, 24- and 36-months post first dose.

Population: All randomized participants.

Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization

Outcome measures

Outcome measures
Measure	Nivolumab n=532 Participants Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.	Placebo n=262 Participants Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
Overall Survival Rates at 12-, 24-, and 36-months 12-months	87.5 Percent of participants Interval 84.4 to 90.0	84.6 Percent of participants Interval 79.6 to 88.4
Overall Survival Rates at 12-, 24-, and 36-months 24-months	68.1 Percent of participants Interval 63.9 to 71.9	65.8 Percent of participants Interval 59.6 to 71.2
Overall Survival Rates at 12-, 24-, and 36-months 36-months	56.9 Percent of participants Interval 52.5 to 61.0	49.7 Percent of participants Interval 43.5 to 55.7

Adverse Events

Nivolumab

Serious events: 196 serious events

Other events: 470 other events

Deaths: 299 deaths

Placebo

Serious events: 99 serious events

Other events: 216 other events

Deaths: 162 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Nivolumab n=532 participants at risk Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.	Placebo n=260 participants at risk Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Blood and lymphatic system disorders Febrile neutropenia	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Blood and lymphatic system disorders Lymphadenopathy	0.38% 2/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Blood and lymphatic system disorders Myelosuppression	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Cardiac disorders Acute myocardial infarction	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Cardiac disorders Atrial fibrillation	0.75% 4/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.38% 1/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Cardiac disorders Atrial flutter	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Cardiac disorders Bradycardia	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Cardiac disorders Cardiac arrest	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.38% 1/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Cardiac disorders Cardiac failure	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Cardiac disorders Myocardial infarction	0.38% 2/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.77% 2/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Cardiac disorders Myocarditis	0.56% 3/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Cardiac disorders Supraventricular tachycardia	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Cardiac disorders Tachycardia	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Cardiac disorders Ventricular extrasystoles	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Endocrine disorders Adrenal insufficiency	0.38% 2/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Endocrine disorders Goitre	0.00% 0/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.38% 1/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Endocrine disorders Hyperthyroidism	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Endocrine disorders Hypophysitis	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Endocrine disorders Hypothyroidism	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Endocrine disorders Thyroiditis	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.38% 1/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Abdominal hernia	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.38% 1/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Abdominal pain	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.38% 1/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Abdominal pain upper	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Anal fistula	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Ascites	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Colitis	0.56% 3/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Diaphragmatic hernia	1.1% 6/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	1.2% 3/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Diarrhoea	0.75% 4/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Dysphagia	0.94% 5/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	2.3% 6/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Enterocutaneous fistula	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Fibrosing colonopathy	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Gastric fistula	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Gastritis	0.00% 0/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.38% 1/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.38% 2/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.38% 1/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Gastrointestinal obstruction	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Gastrointestinal pain	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.19% 1/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.00% 0/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.

Other adverse events
Measure	Nivolumab n=532 participants at risk Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.	Placebo n=260 participants at risk Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
Blood and lymphatic system disorders Anaemia	9.4% 50/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	8.5% 22/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Endocrine disorders Hyperthyroidism	8.3% 44/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	0.77% 2/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Endocrine disorders Hypothyroidism	12.6% 67/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	2.7% 7/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Abdominal pain	13.3% 71/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	15.0% 39/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Abdominal pain upper	3.9% 21/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	7.3% 19/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Constipation	12.2% 65/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	13.8% 36/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Diarrhoea	31.0% 165/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	32.3% 84/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Dry mouth	5.3% 28/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	3.8% 10/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Dysphagia	12.8% 68/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	16.2% 42/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Gastrooesophageal reflux disease	9.0% 48/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	13.8% 36/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Nausea	24.2% 129/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	23.8% 62/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Gastrointestinal disorders Vomiting	16.2% 86/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	16.2% 42/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
General disorders Asthenia	8.1% 43/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	6.2% 16/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
General disorders Fatigue	28.8% 153/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	25.8% 67/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
General disorders Influenza like illness	5.1% 27/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	3.1% 8/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
General disorders Pyrexia	6.4% 34/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	4.2% 11/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Infections and infestations Nasopharyngitis	3.0% 16/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	5.4% 14/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Infections and infestations Pneumonia	5.6% 30/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	4.2% 11/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Infections and infestations Upper respiratory tract infection	3.8% 20/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	5.8% 15/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Investigations Alanine aminotransferase increased	8.1% 43/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	2.3% 6/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Investigations Amylase increased	5.3% 28/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	1.9% 5/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Investigations Aspartate aminotransferase increased	9.6% 51/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	5.4% 14/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Investigations Blood alkaline phosphatase increased	6.2% 33/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	2.3% 6/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Investigations Weight decreased	14.1% 75/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	10.0% 26/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Metabolism and nutrition disorders Decreased appetite	16.4% 87/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	11.5% 30/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Musculoskeletal and connective tissue disorders Arthralgia	13.0% 69/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	11.2% 29/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Musculoskeletal and connective tissue disorders Back pain	7.9% 42/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	9.6% 25/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Musculoskeletal and connective tissue disorders Myalgia	7.3% 39/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	4.6% 12/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Nervous system disorders Dizziness	10.0% 53/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	9.2% 24/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Nervous system disorders Headache	8.1% 43/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	11.5% 30/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Psychiatric disorders Insomnia	5.5% 29/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	4.2% 11/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Respiratory, thoracic and mediastinal disorders Cough	19.9% 106/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	20.4% 53/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.7% 57/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	9.6% 25/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Skin and subcutaneous tissue disorders Dry skin	5.1% 27/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	1.9% 5/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Skin and subcutaneous tissue disorders Pruritus	13.3% 71/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	6.2% 16/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Skin and subcutaneous tissue disorders Rash	12.4% 66/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	6.5% 17/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.
Vascular disorders Hypertension	7.1% 38/532 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.	4.2% 11/260 • All-cause Mortality was collected from randomization until the data cutoff date (up to approximately 60 months). SAEs and Other AEs were collected from the first dose to 30 days following the last dose (an average of 9 months up to a maximum of 16 months). All-cause mortality represents all randomized participants. Serious adverse events (SAEs) and other adverse events (AEs) represents participants who received at least one dose of study medicine.