NCT01721772 · ADVERSE EVENTS

Adverse events

Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma · Source last updated 2022-07-12

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: All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).
Other-event reporting threshold: 5%

All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion	125 / 206	191 / 206	126 / 210
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion	119 / 205	187 / 205	165 / 208

Group identifiers: EG000: Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine · EG001: Dacarbazine, 1000 mg/m^2 + Placebo-matching 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
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
2
num At Risk
205
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
1
num At Risk
205
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
206
group Id
EG001
num Affected
2
num At Risk
205
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
206
group Id
EG001
num Affected
4
num At Risk
205
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
206
group Id
EG001
num Affected
4
num At Risk
205
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
206
group Id
EG001
num Affected
1
num At Risk
205
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
1
num At Risk
205
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
0
num At Risk
205
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
0
num At Risk
205
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
206
group Id
EG001
num Affected
1
num At Risk
205
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
0
num At Risk
205
term
Deafness unilateral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
0
num At Risk
205
term
Vertigo

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
24.0
stats
group Id
EG000
num Affected
26
num At Risk
206
group Id
EG001
num Affected
24
num At Risk
205
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
26
num At Risk
205
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
2
num At Risk
206
group Id
EG001
num Affected
22
num At Risk
205
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
11
num At Risk
206
group Id
EG001
num Affected
3
num At Risk
205
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
20
num At Risk
206
group Id
EG001
num Affected
8
num At Risk
205
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
30
num At Risk
206
group Id
EG001
num Affected
21
num At Risk
205
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
17
num At Risk
206
group Id
EG001
num Affected
12
num At Risk
205
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
57
num At Risk
206
group Id
EG001
num Affected
57
num At Risk
205
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
75
num At Risk
206
group Id
EG001
num Affected
58
num At Risk
205
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
11
num At Risk
206
group Id
EG001
num Affected
7
num At Risk
205
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
59
num At Risk
206
group Id
EG001
num Affected
104
num At Risk
205
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
34
num At Risk
206
group Id
EG001
num Affected
54
num At Risk
205
term
Vomiting

Complete source fields

description

All-Cause Mortality = all randomized participants SAEs and NSAEs (Other Adverse Events) = all treated participants

event Groups

deaths Num Affected
126
deaths Num At Risk
210
description
Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
id
EG000
other Num Affected
191
other Num At Risk
206
serious Num Affected
125
serious Num At Risk
206
title
Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
deaths Num Affected
165
deaths Num At Risk
208
description
Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
id
EG001
other Num Affected
187
other Num At Risk
205
serious Num Affected
119
serious Num At Risk
205
title
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
26
num At Risk
206
group Id
EG001
num Affected
24
num At Risk
205
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
26
num At Risk
205
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
2
num At Risk
206
group Id
EG001
num Affected
22
num At Risk
205
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
11
num At Risk
206
group Id
EG001
num Affected
3
num At Risk
205
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
20
num At Risk
206
group Id
EG001
num Affected
8
num At Risk
205
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
30
num At Risk
206
group Id
EG001
num Affected
21
num At Risk
205
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
17
num At Risk
206
group Id
EG001
num Affected
12
num At Risk
205
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
57
num At Risk
206
group Id
EG001
num Affected
57
num At Risk
205
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
75
num At Risk
206
group Id
EG001
num Affected
58
num At Risk
205
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
11
num At Risk
206
group Id
EG001
num Affected
7
num At Risk
205
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
59
num At Risk
206
group Id
EG001
num Affected
104
num At Risk
205
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
34
num At Risk
206
group Id
EG001
num Affected
54
num At Risk
205
term
Vomiting

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
2
num At Risk
205
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
1
num At Risk
205
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
206
group Id
EG001
num Affected
2
num At Risk
205
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
206
group Id
EG001
num Affected
4
num At Risk
205
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
206
group Id
EG001
num Affected
4
num At Risk
205
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
206
group Id
EG001
num Affected
1
num At Risk
205
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
1
num At Risk
205
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
0
num At Risk
205
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
0
num At Risk
205
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
0
num At Risk
206
group Id
EG001
num Affected
1
num At Risk
205
term
Tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
0
num At Risk
205
term
Deafness unilateral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
24.0
stats
group Id
EG000
num Affected
1
num At Risk
206
group Id
EG001
num Affected
0
num At Risk
205
term
Vertigo

time Frame

All-cause mortality was assessed from date of randomization to study completion (up to approximately 99 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 97 months).

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