NCT02387996 · ADVERSE EVENTS

Adverse events

A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder Cancer · Source last updated 2022-11-01

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 first dose to study completion, (up to approximately 80 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 78 months).
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Nivolumab 3 mg/kg Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W	199 / 270	245 / 270	225 / 270

Group identifiers: EG000: Nivolumab 3 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
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Agranulocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
3
num At Risk
270
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
2
num At Risk
270
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Aortic valve stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
3
num At Risk
270
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Cardiovascular disorder

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
24.1
stats
group Id
EG000
num Affected
58
num At Risk
270
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
32
num At Risk
270
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
34
num At Risk
270
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
60
num At Risk
270
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
60
num At Risk
270
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
71
num At Risk
270
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
42
num At Risk
270
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
43
num At Risk
270
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
22
num At Risk
270
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
97
num At Risk
270
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
45
num At Risk
270
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
65
num At Risk
270
term
Pyrexia

Complete source fields

event Groups

deaths Num Affected
225
deaths Num At Risk
270
description
Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
id
EG000
other Num Affected
245
other Num At Risk
270
serious Num Affected
199
serious Num At Risk
270
title
Nivolumab 3 mg/kg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
58
num At Risk
270
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
32
num At Risk
270
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
34
num At Risk
270
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
60
num At Risk
270
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
60
num At Risk
270
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
71
num At Risk
270
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
42
num At Risk
270
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
43
num At Risk
270
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
22
num At Risk
270
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
97
num At Risk
270
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
45
num At Risk
270
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
65
num At Risk
270
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Agranulocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
3
num At Risk
270
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
2
num At Risk
270
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Aortic valve stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
3
num At Risk
270
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Cardio-respiratory arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
24.1
stats
group Id
EG000
num Affected
1
num At Risk
270
term
Cardiovascular disorder

time Frame

Participants were assessed for all-cause mortality from their first dose to study completion, (up to approximately 80 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 78 months).

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