NCT01721746 · ADVERSE EVENTS

Adverse events

A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037) · Source last updated 2022-04-19

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 100 days post last dose (Up to 96 months)
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Nivolumab Nivolumab 3 mg/kg IV over 60 minutes Q2W	191 / 268	255 / 268	206 / 268
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel) Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W	37 / 102	95 / 102	88 / 102

Group identifiers: EG000: Nivolumab · EG001: Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)

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
23.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
2
num At Risk
102
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
0
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
102
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
2
num At Risk
102
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
2
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Splenic haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Splenic lesion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
102
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
4
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
2
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
3
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Cardiac arrest

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
23.1
stats
group Id
EG000
num Affected
65
num At Risk
268
group Id
EG001
num Affected
31
num At Risk
102
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
4
num At Risk
268
group Id
EG001
num Affected
10
num At Risk
102
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
3
num At Risk
268
group Id
EG001
num Affected
24
num At Risk
102
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
8
num At Risk
268
group Id
EG001
num Affected
11
num At Risk
102
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
27
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
50
num At Risk
268
group Id
EG001
num Affected
13
num At Risk
102
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
21
num At Risk
268
group Id
EG001
num Affected
6
num At Risk
102
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
53
num At Risk
268
group Id
EG001
num Affected
23
num At Risk
102
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
90
num At Risk
268
group Id
EG001
num Affected
18
num At Risk
102
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
14
num At Risk
268
group Id
EG001
num Affected
3
num At Risk
102
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
21
num At Risk
268
group Id
EG001
num Affected
4
num At Risk
102
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
91
num At Risk
268
group Id
EG001
num Affected
43
num At Risk
102
term
Nausea

Complete source fields

event Groups

deaths Num Affected
206
deaths Num At Risk
268
description
Nivolumab 3 mg/kg IV over 60 minutes Q2W
id
EG000
other Num Affected
255
other Num At Risk
268
serious Num Affected
191
serious Num At Risk
268
title
Nivolumab
deaths Num Affected
88
deaths Num At Risk
102
description
Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
id
EG001
other Num Affected
95
other Num At Risk
102
serious Num Affected
37
serious Num At Risk
102
title
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
65
num At Risk
268
group Id
EG001
num Affected
31
num At Risk
102
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
4
num At Risk
268
group Id
EG001
num Affected
10
num At Risk
102
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
3
num At Risk
268
group Id
EG001
num Affected
24
num At Risk
102
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
8
num At Risk
268
group Id
EG001
num Affected
11
num At Risk
102
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
27
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
50
num At Risk
268
group Id
EG001
num Affected
13
num At Risk
102
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
21
num At Risk
268
group Id
EG001
num Affected
6
num At Risk
102
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
53
num At Risk
268
group Id
EG001
num Affected
23
num At Risk
102
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
90
num At Risk
268
group Id
EG001
num Affected
18
num At Risk
102
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
14
num At Risk
268
group Id
EG001
num Affected
3
num At Risk
102
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
21
num At Risk
268
group Id
EG001
num Affected
4
num At Risk
102
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
91
num At Risk
268
group Id
EG001
num Affected
43
num At Risk
102
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
2
num At Risk
102
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Blood loss anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
0
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
102
term
Febrile bone marrow aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
2
num At Risk
102
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
2
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Splenic haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Splenic lesion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
1
num At Risk
102
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
1
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
4
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
2
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.1
stats
group Id
EG000
num Affected
3
num At Risk
268
group Id
EG001
num Affected
0
num At Risk
102
term
Cardiac arrest

time Frame

From first dose to 100 days post last dose (Up to 96 months)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice