Trial Outcomes & Findings for A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma (NCT NCT03470922)

Last Updated: 2025-09-09

Results Overview

Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2/PHASE3

Target enrollment

714 participants

Primary outcome timeframe

From randomization to date of first documented tumor progression or death (up to approximately 33 months)

Results posted on

2025-09-09

Participant Flow

714 Participants were randomized and received study treatment

Participant milestones

Participant milestones
Measure	Arm A: Relatlimab + Nivolumab Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Arm B: Nivolumab Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.
Overall Study STARTED	355	359
Overall Study COMPLETED	237	227
Overall Study NOT COMPLETED	118	132

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Relatlimab + Nivolumab Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Arm B: Nivolumab Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.
Overall Study Death	107	118
Overall Study Lost to Follow-up	5	5
Overall Study Participant Withdrew Consent	4	9
Overall Study Other reasons	1	0
Overall Study Not reported	1	0

Baseline Characteristics

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Relatlimab + Nivolumab n=355 Participants Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Arm B: Nivolumab n=359 Participants Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.	Total n=714 Participants Total of all reporting groups
Age, Continuous	61.2 years STANDARD_DEVIATION 14.1 • n=5 Participants	61.2 years STANDARD_DEVIATION 14.0 • n=7 Participants	61.2 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	145 Participants n=5 Participants	153 Participants n=7 Participants	298 Participants n=5 Participants
Sex: Female, Male Male	210 Participants n=5 Participants	206 Participants n=7 Participants	416 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	20 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	144 Participants n=5 Participants	147 Participants n=7 Participants	291 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	184 Participants n=5 Participants	192 Participants n=7 Participants	376 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	342 Participants n=5 Participants	348 Participants n=7 Participants	690 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to date of first documented tumor progression or death (up to approximately 33 months)

Population: All randomized participants

Outcome measures

Outcome measures
Measure	Arm A: Relatlimab + Nivolumab n=355 Participants Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Arm B: Nivolumab n=359 Participants Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.
Progression Free Survival (PFS)	10.12 Months Interval 6.37 to 15.74	4.63 Months Interval 3.38 to 5.62

SECONDARY outcome

Timeframe: From randomization to the date of death (up to approximately 3 years)

Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date").

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization up to approximately 3 years

Objective response rate (ORR) is defined as the number of randomized subjects who achieve a best response of complete response (CR) or partial response (PR) based on BICR assessments (using RECIST v1.1 criteria).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

Population: All treated participants

The number of participants experiencing adverse events (AEs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Arm A: Relatlimab + Nivolumab n=355 Participants Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Arm B: Nivolumab n=359 Participants Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.
The Number of Participants Experiencing Adverse Events (AEs)	345 Participants	339 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

Population: All treated participants

The number of participants experiencing serious adverse events (SAEs). A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.

Outcome measures

Outcome measures
Measure	Arm A: Relatlimab + Nivolumab n=355 Participants Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Arm B: Nivolumab n=359 Participants Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.
The Number of Participants Experiencing Serious Adverse Events (SAEs)	121 Participants	105 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

Population: All treated participants

The number of participants experiencing adverse events (AEs) leading to discontinuation. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

Outcome measures

Outcome measures
Measure	Arm A: Relatlimab + Nivolumab n=355 Participants Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Arm B: Nivolumab n=359 Participants Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation	69 Participants	41 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose up to approximately 33 months

Population: All treated participants

The number of participant deaths in the study.

Outcome measures

Outcome measures
Measure	Arm A: Relatlimab + Nivolumab n=355 Participants Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Arm B: Nivolumab n=359 Participants Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.
The Number of Participant Deaths in the Study	108 Participants	119 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

Population: All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter

The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units.

Outcome measures

Outcome measures
Measure	Arm A: Relatlimab + Nivolumab n=342 Participants Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Arm B: Nivolumab n=345 Participants Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT OR AST > 3XULN	26 Participants	15 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT OR AST> 5XULN	11 Participants	7 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT OR AST> 10XULN	4 Participants	4 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT OR AST > 20XULN	0 Participants	2 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests TOTAL BILIRUBIN > 2XULN	2 Participants	5 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY	2 Participants	1 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS	2 Participants	1 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALP > 1.5xULN	34 Participants	30 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 1 DAY	2 Participants	2 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>1.5XULN IN 30 DAYS	2 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose to 30 days after last dose of study therapy (up to approximately 33 months)

Population: All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter.

The number of participants with clinical laboratory test abnormalities in specific thyroid tests based on US conventional units.

Outcome measures

Outcome measures
Measure	Arm A: Relatlimab + Nivolumab n=328 Participants Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Arm B: Nivolumab n=333 Participants Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests TSH < LLN	89 Participants	84 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests TSH <LLN WITH TSH >= LLN AT BASELINE	79 Participants	78 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN	51 Participants	40 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN	6 Participants	3 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests TSH < LLN WITH FT3/FT4 TEST MISSING	11 Participants	7 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests TSH > ULN	106 Participants	106 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests TSH > ULN WITH TSH <= ULN AT BASELINE	84 Participants	82 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN	63 Participants	48 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN	7 Participants	7 Participants
The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests TSH > ULN WITH FT3/FT4 TEST MISSING	8 Participants	9 Participants

Adverse Events

Arm A: Relatlimab + Nivolumab

Serious events: 155 serious events

Other events: 314 other events

Deaths: 108 deaths

Arm B: Nivolumab

Serious events: 140 serious events

Other events: 298 other events

Deaths: 119 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	Arm A: Relatlimab + Nivolumab n=355 participants at risk Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Arm B: Nivolumab n=359 participants at risk Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.
Blood and lymphatic system disorders Acquired haemophilia	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Blood and lymphatic system disorders Anaemia	1.4% 5/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	1.1% 4/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Blood and lymphatic system disorders Bone marrow failure	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Blood and lymphatic system disorders Haemolytic anaemia	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Acute myocardial infarction	1.1% 4/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.56% 2/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Arrhythmia	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Atrial fibrillation	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Bradycardia	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Cardiac disorder	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Cardiac failure	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Cardiac failure congestive	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Cardiogenic shock	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Coronary artery disease	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Heart valve incompetence	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Immune-mediated myocarditis	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Myocardial infarction	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Myocardial ischaemia	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.56% 2/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Myocarditis	1.1% 4/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Palpitations	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Right ventricular dysfunction	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Sinus tachycardia	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Cardiac disorders Ventricular extrasystoles	0.56% 2/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Ear and labyrinth disorders Vertigo	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Endocrine disorders Adrenal insufficiency	1.4% 5/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Endocrine disorders Adrenocortical insufficiency acute	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Endocrine disorders Adrenocorticotropic hormone deficiency	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Endocrine disorders Autoimmune thyroiditis	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Endocrine disorders Hyperthyroidism	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Endocrine disorders Hypophysitis	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Endocrine disorders Hypothyroidism	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Endocrine disorders Lymphocytic hypophysitis	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Eye disorders Autoimmune uveitis	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Eye disorders Papilloedema	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Eye disorders Ulcerative keratitis	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Eye disorders Vision blurred	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Eye disorders Vogt-Koyanagi-Harada disease	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Gastrointestinal disorders Abdominal distension	0.28% 1/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Gastrointestinal disorders Abdominal pain	0.85% 3/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.00% 0/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Gastrointestinal disorders Ascites	0.00% 0/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	0.28% 1/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.

Other adverse events
Measure	Arm A: Relatlimab + Nivolumab n=355 participants at risk Participants receive BMS-986213 (IV fixed-dose combination relatlimab/nivolumab at a 1:3 ratio) every 4 weeks (Q4W). For adults, dosing is relatlimab 160 mg/nivolumab 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is relatlimab 2 mg/kg/nivolumab 6 mg/kg.	Arm B: Nivolumab n=359 participants at risk Participants receive Nivolumab IV monotherapy every 4 weeks (Q4W). Dosing for adults is 480 mg. Adolescents ≥ 40 kg will receive adult dosing; for adolescents \< 40 kg, dosing is 6 mg/kg.
Blood and lymphatic system disorders Anaemia	14.1% 50/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	10.3% 37/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Endocrine disorders Hyperthyroidism	6.5% 23/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	7.8% 28/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Endocrine disorders Hypothyroidism	16.3% 58/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	13.1% 47/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Gastrointestinal disorders Abdominal pain	8.7% 31/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	8.6% 31/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Gastrointestinal disorders Constipation	11.0% 39/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	7.0% 25/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Gastrointestinal disorders Diarrhoea	23.1% 82/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	17.3% 62/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Gastrointestinal disorders Dry mouth	7.9% 28/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	5.0% 18/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Gastrointestinal disorders Nausea	17.7% 63/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	16.4% 59/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Gastrointestinal disorders Vomiting	9.3% 33/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	5.6% 20/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
General disorders Asthenia	13.5% 48/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	9.2% 33/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
General disorders Fatigue	29.3% 104/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	20.6% 74/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
General disorders Influenza like illness	5.4% 19/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	3.9% 14/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
General disorders Oedema peripheral	7.3% 26/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	5.8% 21/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
General disorders Pyrexia	12.4% 44/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	9.2% 33/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Infections and infestations Urinary tract infection	10.7% 38/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	8.1% 29/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Injury, poisoning and procedural complications Infusion related reaction	5.9% 21/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	3.3% 12/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Investigations Alanine aminotransferase increased	10.1% 36/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	5.8% 21/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Investigations Aspartate aminotransferase increased	9.9% 35/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	4.7% 17/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Investigations Blood creatinine increased	5.9% 21/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	3.3% 12/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Investigations Troponin increased	7.6% 27/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	5.0% 18/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Investigations Weight decreased	7.6% 27/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	4.2% 15/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Metabolism and nutrition disorders Decreased appetite	15.5% 55/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	7.5% 27/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Metabolism and nutrition disorders Hyperglycaemia	5.4% 19/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	6.7% 24/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Musculoskeletal and connective tissue disorders Arthralgia	23.7% 84/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	15.0% 54/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Musculoskeletal and connective tissue disorders Back pain	13.5% 48/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	8.4% 30/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Musculoskeletal and connective tissue disorders Myalgia	9.6% 34/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	5.3% 19/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Musculoskeletal and connective tissue disorders Pain in extremity	7.9% 28/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	4.5% 16/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Nervous system disorders Dizziness	5.9% 21/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	6.7% 24/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Nervous system disorders Headache	18.0% 64/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	13.1% 47/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Nervous system disorders Paraesthesia	5.1% 18/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	1.4% 5/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Respiratory, thoracic and mediastinal disorders Cough	14.1% 50/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	10.6% 38/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.3% 33/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	6.1% 22/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Skin and subcutaneous tissue disorders Pruritus	24.8% 88/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	17.3% 62/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Skin and subcutaneous tissue disorders Rash	17.5% 62/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	13.6% 49/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Skin and subcutaneous tissue disorders Vitiligo	11.0% 39/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	10.3% 37/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.
Vascular disorders Hypertension	5.9% 21/355 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.	3.9% 14/359 • From first dose to up to 100 days post last dose (up to approximately 33 months) There was a participant in each arm that discontinued the study for reasons unrelated to death but whose deaths records were later discovered in a public search after discontinuation so were included in the All-cause mortality totals.