NCT02388906 · ADVERSE EVENTS

Adverse events

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma · Source last updated 2025-04-24

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: Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 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 3 mg/kg Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24	106 / 452	421 / 452	128 / 452
Ipilimumab 10 mg/kg Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks	215 / 453	438 / 453	142 / 453

Group identifiers: EG000: Nivolumab 3 mg/kg · EG001: Ipilimumab 10 mg/kg

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
27.1
stats
group Id
EG000
num Affected
0
num At Risk
452
group Id
EG001
num Affected
1
num At Risk
453
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
2
num At Risk
452
group Id
EG001
num Affected
0
num At Risk
453
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
452
group Id
EG001
num Affected
0
num At Risk
453
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
0
num At Risk
452
group Id
EG001
num Affected
3
num At Risk
453
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
452
group Id
EG001
num Affected
0
num At Risk
453
term
Lymphadenopathy mediastinal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
452
group Id
EG001
num Affected
1
num At Risk
453
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
0
num At Risk
452
group Id
EG001
num Affected
1
num At Risk
453
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
452
group Id
EG001
num Affected
0
num At Risk
453
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
452
group Id
EG001
num Affected
2
num At Risk
453
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
0
num At Risk
452
group Id
EG001
num Affected
1
num At Risk
453
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
0
num At Risk
452
group Id
EG001
num Affected
1
num At Risk
453
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
452
group Id
EG001
num Affected
0
num At Risk
453
term
Myocardial ischaemia

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
27.1
stats
group Id
EG000
num Affected
13
num At Risk
452
group Id
EG001
num Affected
26
num At Risk
453
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
37
num At Risk
452
group Id
EG001
num Affected
22
num At Risk
453
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
6
num At Risk
452
group Id
EG001
num Affected
42
num At Risk
453
term
Hypophysitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
53
num At Risk
452
group Id
EG001
num Affected
35
num At Risk
453
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
53
num At Risk
452
group Id
EG001
num Affected
78
num At Risk
453
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
33
num At Risk
452
group Id
EG001
num Affected
21
num At Risk
453
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
10
num At Risk
452
group Id
EG001
num Affected
30
num At Risk
453
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
47
num At Risk
452
group Id
EG001
num Affected
46
num At Risk
453
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
171
num At Risk
452
group Id
EG001
num Affected
250
num At Risk
453
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
33
num At Risk
452
group Id
EG001
num Affected
23
num At Risk
453
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
21
num At Risk
452
group Id
EG001
num Affected
27
num At Risk
453
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
110
num At Risk
452
group Id
EG001
num Affected
135
num At Risk
453
term
Nausea

Complete source fields

description

event Groups

deaths Num Affected
128
deaths Num At Risk
452
description
Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
id
EG000
other Num Affected
421
other Num At Risk
452
serious Num Affected
106
serious Num At Risk
452
title
Nivolumab 3 mg/kg
deaths Num Affected
142
deaths Num At Risk
453
description
Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
id
EG001
other Num Affected
438
other Num At Risk
453
serious Num Affected
215
serious Num At Risk
453
title
Ipilimumab 10 mg/kg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
13
num At Risk
452
group Id
EG001
num Affected
26
num At Risk
453
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
37
num At Risk
452
group Id
EG001
num Affected
22
num At Risk
453
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
6
num At Risk
452
group Id
EG001
num Affected
42
num At Risk
453
term
Hypophysitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
53
num At Risk
452
group Id
EG001
num Affected
35
num At Risk
453
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
53
num At Risk
452
group Id
EG001
num Affected
78
num At Risk
453
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
33
num At Risk
452
group Id
EG001
num Affected
21
num At Risk
453
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
10
num At Risk
452
group Id
EG001
num Affected
30
num At Risk
453
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
47
num At Risk
452
group Id
EG001
num Affected
46
num At Risk
453
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
171
num At Risk
452
group Id
EG001
num Affected
250
num At Risk
453
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
33
num At Risk
452
group Id
EG001
num Affected
23
num At Risk
453
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
21
num At Risk
452
group Id
EG001
num Affected
27
num At Risk
453
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
110
num At Risk
452
group Id
EG001
num Affected
135
num At Risk
453
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
0
num At Risk
452
group Id
EG001
num Affected
1
num At Risk
453
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
2
num At Risk
452
group Id
EG001
num Affected
0
num At Risk
453
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
452
group Id
EG001
num Affected
0
num At Risk
453
term
Lymph node pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
0
num At Risk
452
group Id
EG001
num Affected
3
num At Risk
453
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
452
group Id
EG001
num Affected
0
num At Risk
453
term
Lymphadenopathy mediastinal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
452
group Id
EG001
num Affected
1
num At Risk
453
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
0
num At Risk
452
group Id
EG001
num Affected
1
num At Risk
453
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
452
group Id
EG001
num Affected
0
num At Risk
453
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
452
group Id
EG001
num Affected
2
num At Risk
453
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
0
num At Risk
452
group Id
EG001
num Affected
1
num At Risk
453
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
0
num At Risk
452
group Id
EG001
num Affected
1
num At Risk
453
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
27.1
stats
group Id
EG000
num Affected
1
num At Risk
452
group Id
EG001
num Affected
0
num At Risk
453
term
Myocardial ischaemia

time Frame

Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): approximately up to 16 Months All-Cause mortality (From first dose to end of study): Approximately Up to 114 Months

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Preserved source evidence · Not medical advice