NCT03470922 · ADVERSE EVENTS

Adverse events

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma · Source last updated 2025-09-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From first dose to up to 100 days post last dose (up to approximately 33 months)
Other-event reporting threshold: 5%

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.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	155 / 355	314 / 355	108 / 355
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.	140 / 359	298 / 359	119 / 359

Group identifiers: EG000: Arm A: Relatlimab + Nivolumab · EG001: Arm B: Nivolumab

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
359
term
Acquired haemophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
5
num At Risk
355
group Id
EG001
num Affected
4
num At Risk
359
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
359
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
359
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
4
num At Risk
355
group Id
EG001
num Affected
2
num At Risk
359
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
359
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
359
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
359
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
359
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
359
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
359
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
359
term
Cardiogenic shock

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
50
num At Risk
355
group Id
EG001
num Affected
37
num At Risk
359
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
23
num At Risk
355
group Id
EG001
num Affected
28
num At Risk
359
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
58
num At Risk
355
group Id
EG001
num Affected
47
num At Risk
359
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
31
num At Risk
355
group Id
EG001
num Affected
31
num At Risk
359
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
39
num At Risk
355
group Id
EG001
num Affected
25
num At Risk
359
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
82
num At Risk
355
group Id
EG001
num Affected
62
num At Risk
359
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
28
num At Risk
355
group Id
EG001
num Affected
18
num At Risk
359
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
63
num At Risk
355
group Id
EG001
num Affected
59
num At Risk
359
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
33
num At Risk
355
group Id
EG001
num Affected
20
num At Risk
359
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
48
num At Risk
355
group Id
EG001
num Affected
33
num At Risk
359
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
104
num At Risk
355
group Id
EG001
num Affected
74
num At Risk
359
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
19
num At Risk
355
group Id
EG001
num Affected
14
num At Risk
359
term
Influenza like illness

Complete source fields

description

event Groups

deaths Num Affected
108
deaths Num At Risk
355
description
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.
id
EG000
other Num Affected
314
other Num At Risk
355
serious Num Affected
155
serious Num At Risk
355
title
Arm A: Relatlimab + Nivolumab
deaths Num Affected
119
deaths Num At Risk
359
description
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.
id
EG001
other Num Affected
298
other Num At Risk
359
serious Num Affected
140
serious Num At Risk
359
title
Arm B: Nivolumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
50
num At Risk
355
group Id
EG001
num Affected
37
num At Risk
359
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
23
num At Risk
355
group Id
EG001
num Affected
28
num At Risk
359
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
58
num At Risk
355
group Id
EG001
num Affected
47
num At Risk
359
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
31
num At Risk
355
group Id
EG001
num Affected
31
num At Risk
359
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
39
num At Risk
355
group Id
EG001
num Affected
25
num At Risk
359
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
82
num At Risk
355
group Id
EG001
num Affected
62
num At Risk
359
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
28
num At Risk
355
group Id
EG001
num Affected
18
num At Risk
359
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
63
num At Risk
355
group Id
EG001
num Affected
59
num At Risk
359
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
33
num At Risk
355
group Id
EG001
num Affected
20
num At Risk
359
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
48
num At Risk
355
group Id
EG001
num Affected
33
num At Risk
359
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
104
num At Risk
355
group Id
EG001
num Affected
74
num At Risk
359
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
19
num At Risk
355
group Id
EG001
num Affected
14
num At Risk
359
term
Influenza like illness

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
359
term
Acquired haemophilia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
5
num At Risk
355
group Id
EG001
num Affected
4
num At Risk
359
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
359
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
359
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
4
num At Risk
355
group Id
EG001
num Affected
2
num At Risk
359
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
359
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
359
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
359
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
1
num At Risk
355
group Id
EG001
num Affected
0
num At Risk
359
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
359
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
359
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 23.1
stats
group Id
EG000
num Affected
0
num At Risk
355
group Id
EG001
num Affected
1
num At Risk
359
term
Cardiogenic shock

time Frame

From first dose to up to 100 days post last dose (up to approximately 33 months)

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Preserved source evidence · Not medical advice