NCT04099251 · ADVERSE EVENTS

Adverse events

Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma · Source last updated 2026-08-07

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: Participants were assessed for all-cause mortality from their randomization to primary completion, (up to approximately 32 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 32 months)
Other-event reporting threshold: 5%

The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Nivolumab Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date.	95 / 524	464 / 524	14 / 526
Placebo Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first.	37 / 264	194 / 264	8 / 264
Open-Label Nivolumab In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.	5 / 30	20 / 30	2 / 32

Group identifiers: EG000: Nivolumab · EG001: Placebo · EG002: Open-Label 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
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
2
num At Risk
524
group Id
EG001
num Affected
1
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
2
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
2
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
3
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Hyperthyroidism

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
Endocrine disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
41
num At Risk
524
group Id
EG001
num Affected
4
num At Risk
264
group Id
EG002
num Affected
2
num At Risk
30
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
63
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
2
num At Risk
30
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
22
num At Risk
524
group Id
EG001
num Affected
14
num At Risk
264
group Id
EG002
num Affected
1
num At Risk
30
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
50
num At Risk
524
group Id
EG001
num Affected
18
num At Risk
264
group Id
EG002
num Affected
3
num At Risk
30
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
121
num At Risk
524
group Id
EG001
num Affected
44
num At Risk
264
group Id
EG002
num Affected
3
num At Risk
30
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
41
num At Risk
524
group Id
EG001
num Affected
10
num At Risk
264
group Id
EG002
num Affected
4
num At Risk
30
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
0
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
2
num At Risk
30
term
Eructation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
78
num At Risk
524
group Id
EG001
num Affected
30
num At Risk
264
group Id
EG002
num Affected
1
num At Risk
30
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
19
num At Risk
524
group Id
EG001
num Affected
12
num At Risk
264
group Id
EG002
num Affected
2
num At Risk
30
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
63
num At Risk
524
group Id
EG001
num Affected
25
num At Risk
264
group Id
EG002
num Affected
4
num At Risk
30
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
140
num At Risk
524
group Id
EG001
num Affected
67
num At Risk
264
group Id
EG002
num Affected
6
num At Risk
30
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
11
num At Risk
524
group Id
EG001
num Affected
5
num At Risk
264
group Id
EG002
num Affected
2
num At Risk
30
term
Pain

Complete source fields

description

event Groups

deaths Num Affected
14
deaths Num At Risk
526
description
Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first. Participants began study treatment (Cycle 1) within 3 calendar days of randomization. Subsequent cycles were initiated within ± 3 days of the target visit date.
id
EG000
other Num Affected
464
other Num At Risk
524
serious Num Affected
95
serious Num At Risk
524
title
Nivolumab
deaths Num Affected
8
deaths Num At Risk
264
description
Nivolumab matched placebo (0.9% Sodium Chloride for Injection/5% Dextrose for Injection) IV in a 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, withdrawal of consent, completion of 12 months of treatment (from first dose of study treatment), disease recurrence, or the study ends, whichever occurred first.
id
EG001
other Num Affected
194
other Num At Risk
264
serious Num Affected
37
serious Num At Risk
264
title
Placebo
deaths Num Affected
2
deaths Num At Risk
32
description
In the event of disease recurrence, participants on the blinded nivolumab or placebo portion will be offered the option to receive open-label on-protocol nivolumab treatment. Participants received 480 mg IV Nivolumab in an approximately 30-minute infusion on Day 1 of each 4-week treatment cycle until unacceptable toxicity, recurrence/progression, withdrawal of consent, completion of 12 months of treatment from first dose of open-label study treatment, whichever occurred first.
id
EG002
other Num Affected
20
other Num At Risk
30
serious Num Affected
5
serious Num At Risk
30
title
Open-Label Nivolumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
41
num At Risk
524
group Id
EG001
num Affected
4
num At Risk
264
group Id
EG002
num Affected
2
num At Risk
30
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
63
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
2
num At Risk
30
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
22
num At Risk
524
group Id
EG001
num Affected
14
num At Risk
264
group Id
EG002
num Affected
1
num At Risk
30
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
50
num At Risk
524
group Id
EG001
num Affected
18
num At Risk
264
group Id
EG002
num Affected
3
num At Risk
30
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
121
num At Risk
524
group Id
EG001
num Affected
44
num At Risk
264
group Id
EG002
num Affected
3
num At Risk
30
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
41
num At Risk
524
group Id
EG001
num Affected
10
num At Risk
264
group Id
EG002
num Affected
4
num At Risk
30
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
0
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
2
num At Risk
30
term
Eructation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
78
num At Risk
524
group Id
EG001
num Affected
30
num At Risk
264
group Id
EG002
num Affected
1
num At Risk
30
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
19
num At Risk
524
group Id
EG001
num Affected
12
num At Risk
264
group Id
EG002
num Affected
2
num At Risk
30
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
63
num At Risk
524
group Id
EG001
num Affected
25
num At Risk
264
group Id
EG002
num Affected
4
num At Risk
30
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
140
num At Risk
524
group Id
EG001
num Affected
67
num At Risk
264
group Id
EG002
num Affected
6
num At Risk
30
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
11
num At Risk
524
group Id
EG001
num Affected
5
num At Risk
264
group Id
EG002
num Affected
2
num At Risk
30
term
Pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
2
num At Risk
524
group Id
EG001
num Affected
1
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
2
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Myocardial ischaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
2
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
3
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
25.0
stats
group Id
EG000
num Affected
1
num At Risk
524
group Id
EG001
num Affected
0
num At Risk
264
group Id
EG002
num Affected
0
num At Risk
30
term
Hyperthyroidism

time Frame

Participants were assessed for all-cause mortality from their randomization to primary completion, (up to approximately 32 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 32 months)

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