NCT02632409 · ADVERSE EVENTS

Adverse events

An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer · Source last updated 2026-07-30

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: appoximately up to 55 months
Other-event reporting threshold: 5%

All Treated Participants All cause mortality is currently blinded at this time and will not be reported.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo Placebo	129 / 348	307 / 348	0 / 0
Nivolumab Nivolumab 240mg IV Q2W	122 / 351	332 / 351	0 / 0

Group identifiers: EG000: Placebo · EG001: 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
23.0
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
0
num At Risk
351
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
351
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
351
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
0
num At Risk
351
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
351
term
Arteriosclerosis coronary artery
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
3
num At Risk
351
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
351
term
Atrioventricular block
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
351
term
Atrioventricular block complete
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
2
num At Risk
348
group Id
EG001
num Affected
0
num At Risk
351
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
351
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
3
num At Risk
351
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
351
term
Coronary artery stenosis

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
23.0
stats
group Id
EG000
num Affected
41
num At Risk
348
group Id
EG001
num Affected
53
num At Risk
351
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
4
num At Risk
348
group Id
EG001
num Affected
37
num At Risk
351
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
9
num At Risk
348
group Id
EG001
num Affected
41
num At Risk
351
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
42
num At Risk
348
group Id
EG001
num Affected
37
num At Risk
351
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
57
num At Risk
348
group Id
EG001
num Affected
50
num At Risk
351
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
92
num At Risk
348
group Id
EG001
num Affected
105
num At Risk
351
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
2
num At Risk
348
group Id
EG001
num Affected
20
num At Risk
351
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
52
num At Risk
348
group Id
EG001
num Affected
63
num At Risk
351
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
31
num At Risk
348
group Id
EG001
num Affected
31
num At Risk
351
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
23.0
stats
group Id
EG000
num Affected
31
num At Risk
348
group Id
EG001
num Affected
42
num At Risk
351
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
23.0
stats
group Id
EG000
num Affected
89
num At Risk
348
group Id
EG001
num Affected
99
num At Risk
351
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
23.0
stats
group Id
EG000
num Affected
26
num At Risk
348
group Id
EG001
num Affected
32
num At Risk
351
term
Oedema peripheral

Complete source fields

description

All Treated Participants All cause mortality is currently blinded at this time and will not be reported.

event Groups

deaths Num Affected
0
deaths Num At Risk
0
description
Placebo
id
EG000
other Num Affected
307
other Num At Risk
348
serious Num Affected
129
serious Num At Risk
348
title
Placebo
deaths Num Affected
0
deaths Num At Risk
0
description
Nivolumab 240mg IV Q2W
id
EG001
other Num Affected
332
other Num At Risk
351
serious Num Affected
122
serious Num At Risk
351
title
Nivolumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
41
num At Risk
348
group Id
EG001
num Affected
53
num At Risk
351
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
4
num At Risk
348
group Id
EG001
num Affected
37
num At Risk
351
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
9
num At Risk
348
group Id
EG001
num Affected
41
num At Risk
351
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
42
num At Risk
348
group Id
EG001
num Affected
37
num At Risk
351
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
57
num At Risk
348
group Id
EG001
num Affected
50
num At Risk
351
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
92
num At Risk
348
group Id
EG001
num Affected
105
num At Risk
351
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
2
num At Risk
348
group Id
EG001
num Affected
20
num At Risk
351
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
52
num At Risk
348
group Id
EG001
num Affected
63
num At Risk
351
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
31
num At Risk
348
group Id
EG001
num Affected
31
num At Risk
351
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
23.0
stats
group Id
EG000
num Affected
31
num At Risk
348
group Id
EG001
num Affected
42
num At Risk
351
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
23.0
stats
group Id
EG000
num Affected
89
num At Risk
348
group Id
EG001
num Affected
99
num At Risk
351
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
23.0
stats
group Id
EG000
num Affected
26
num At Risk
348
group Id
EG001
num Affected
32
num At Risk
351
term
Oedema peripheral

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
0
num At Risk
351
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
351
term
Bone marrow failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
351
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
0
num At Risk
351
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
351
term
Arteriosclerosis coronary artery
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
3
num At Risk
351
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
351
term
Atrioventricular block
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
1
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
351
term
Atrioventricular block complete
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
2
num At Risk
348
group Id
EG001
num Affected
0
num At Risk
351
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
351
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
3
num At Risk
351
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
23.0
stats
group Id
EG000
num Affected
0
num At Risk
348
group Id
EG001
num Affected
1
num At Risk
351
term
Coronary artery stenosis

time Frame

appoximately up to 55 months

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

Preserved source evidence · Not medical advice