NCT00661609 · ADVERSE EVENTS

Adverse events

A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer · Source last updated 2011-01-12

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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
AZD4877 AZD4877 25 mg (Intravenous (IV), 25mg weekly)	14 / 41	38 / 41	Not reported / Not reported

Group identifiers: EG000: AZD4877

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
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Acute Myocardial Infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Cardiac Failure Congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Ventricular Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Chest Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
41
term
Urinary Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Narcotic Intoxication

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
MedDRA 12.0
stats
group Id
EG000
num Affected
23
num At Risk
41
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
11
num At Risk
41
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
7
num At Risk
41
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
11
num At Risk
41
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
8
num At Risk
41
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
8
num At Risk
41
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
5
num At Risk
41
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
5
num At Risk
41
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
3
num At Risk
41
term
Abdominal Discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
3
num At Risk
41
term
Abdominal Distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
13
num At Risk
41
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
7
num At Risk
41
term
Pyrexia

Complete source fields

event Groups

description
AZD4877 25 mg (Intravenous (IV), 25mg weekly)
id
EG000
other Num Affected
38
other Num At Risk
41
serious Num Affected
14
serious Num At Risk
41
title
AZD4877

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
23
num At Risk
41
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
11
num At Risk
41
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
7
num At Risk
41
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
11
num At Risk
41
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
8
num At Risk
41
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
8
num At Risk
41
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
5
num At Risk
41
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
5
num At Risk
41
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
3
num At Risk
41
term
Abdominal Discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
3
num At Risk
41
term
Abdominal Distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
13
num At Risk
41
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (12.0)
stats
group Id
EG000
num Affected
7
num At Risk
41
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Acute Myocardial Infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Cardiac Failure Congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Ventricular Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Chest Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
41
term
Urinary Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
41
term
Narcotic Intoxication

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