NCT00887198 · ADVERSE EVENTS

Adverse events

Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer · Source last updated 2025-02-04

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 of study drug up to 30 days after the last dose of study drug (Approximately 5 years)
Other-event reporting threshold: 5%

Safety analysis set included all participants in the randomized population who received any study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Abiraterone Acetate + Prednisone (AAP) Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4\*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	215 / 542	530 / 542	Not reported / Not reported
Placebo Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.	156 / 540	505 / 540	Not reported / Not reported
Placebo to AA Participants who were originally assigned to placebo were later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4\*250 mg tablets) along with prednisone 5 mg tablet.	40 / 93	86 / 93	Not reported / Not reported

Group identifiers: EG000: Abiraterone Acetate + Prednisone (AAP) · EG001: Placebo · EG002: Placebo to AA

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
8
num At Risk
542
group Id
EG001
num Affected
6
num At Risk
540
group Id
EG002
num Affected
1
num At Risk
93
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
1
num At Risk
542
group Id
EG001
num Affected
0
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Coagulopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
0
num At Risk
542
group Id
EG001
num Affected
1
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
0
num At Risk
542
group Id
EG001
num Affected
0
num At Risk
540
group Id
EG002
num Affected
1
num At Risk
93
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
1
num At Risk
542
group Id
EG001
num Affected
1
num At Risk
540
group Id
EG002
num Affected
1
num At Risk
93
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
1
num At Risk
542
group Id
EG001
num Affected
0
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Tachyarrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
1
num At Risk
542
group Id
EG001
num Affected
0
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Hypoacusis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
1
num At Risk
542
group Id
EG001
num Affected
0
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
0
num At Risk
542
group Id
EG001
num Affected
1
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
1
num At Risk
542
group Id
EG001
num Affected
0
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
2
num At Risk
542
group Id
EG001
num Affected
0
num At Risk
540
group Id
EG002
num Affected
1
num At Risk
93
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
1
num At Risk
542
group Id
EG001
num Affected
1
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Dyspepsia

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
59
num At Risk
542
group Id
EG001
num Affected
53
num At Risk
540
group Id
EG002
num Affected
12
num At Risk
93
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
144
num At Risk
542
group Id
EG001
num Affected
112
num At Risk
540
group Id
EG002
num Affected
15
num At Risk
93
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
135
num At Risk
542
group Id
EG001
num Affected
98
num At Risk
540
group Id
EG002
num Affected
13
num At Risk
93
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
62
num At Risk
542
group Id
EG001
num Affected
28
num At Risk
540
group Id
EG002
num Affected
1
num At Risk
93
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
144
num At Risk
542
group Id
EG001
num Affected
127
num At Risk
540
group Id
EG002
num Affected
15
num At Risk
93
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
86
num At Risk
542
group Id
EG001
num Affected
61
num At Risk
540
group Id
EG002
num Affected
12
num At Risk
93
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
46
num At Risk
542
group Id
EG001
num Affected
46
num At Risk
540
group Id
EG002
num Affected
1
num At Risk
93
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
243
num At Risk
542
group Id
EG001
num Affected
200
num At Risk
540
group Id
EG002
num Affected
27
num At Risk
93
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
54
num At Risk
542
group Id
EG001
num Affected
33
num At Risk
540
group Id
EG002
num Affected
5
num At Risk
93
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
34
num At Risk
542
group Id
EG001
num Affected
14
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
65
num At Risk
542
group Id
EG001
num Affected
46
num At Risk
540
group Id
EG002
num Affected
5
num At Risk
93
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
29
num At Risk
542
group Id
EG001
num Affected
5
num At Risk
540
group Id
EG002
num Affected
3
num At Risk
93
term
Sinusitis

Complete source fields

description

Safety analysis set included all participants in the randomized population who received any study drug.

event Groups

description
Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4\*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
id
EG000
other Num Affected
530
other Num At Risk
542
serious Num Affected
215
serious Num At Risk
542
title
Abiraterone Acetate + Prednisone (AAP)
description
Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
id
EG001
other Num Affected
505
other Num At Risk
540
serious Num Affected
156
serious Num At Risk
540
title
Placebo
description
Participants who were originally assigned to placebo were later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4\*250 mg tablets) along with prednisone 5 mg tablet.
id
EG002
other Num Affected
86
other Num At Risk
93
serious Num Affected
40
serious Num At Risk
93
title
Placebo to AA

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
59
num At Risk
542
group Id
EG001
num Affected
53
num At Risk
540
group Id
EG002
num Affected
12
num At Risk
93
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
144
num At Risk
542
group Id
EG001
num Affected
112
num At Risk
540
group Id
EG002
num Affected
15
num At Risk
93
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
135
num At Risk
542
group Id
EG001
num Affected
98
num At Risk
540
group Id
EG002
num Affected
13
num At Risk
93
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
62
num At Risk
542
group Id
EG001
num Affected
28
num At Risk
540
group Id
EG002
num Affected
1
num At Risk
93
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
144
num At Risk
542
group Id
EG001
num Affected
127
num At Risk
540
group Id
EG002
num Affected
15
num At Risk
93
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
86
num At Risk
542
group Id
EG001
num Affected
61
num At Risk
540
group Id
EG002
num Affected
12
num At Risk
93
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
46
num At Risk
542
group Id
EG001
num Affected
46
num At Risk
540
group Id
EG002
num Affected
1
num At Risk
93
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
243
num At Risk
542
group Id
EG001
num Affected
200
num At Risk
540
group Id
EG002
num Affected
27
num At Risk
93
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
54
num At Risk
542
group Id
EG001
num Affected
33
num At Risk
540
group Id
EG002
num Affected
5
num At Risk
93
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
34
num At Risk
542
group Id
EG001
num Affected
14
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
65
num At Risk
542
group Id
EG001
num Affected
46
num At Risk
540
group Id
EG002
num Affected
5
num At Risk
93
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
29
num At Risk
542
group Id
EG001
num Affected
5
num At Risk
540
group Id
EG002
num Affected
3
num At Risk
93
term
Sinusitis

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
8
num At Risk
542
group Id
EG001
num Affected
6
num At Risk
540
group Id
EG002
num Affected
1
num At Risk
93
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
1
num At Risk
542
group Id
EG001
num Affected
0
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Coagulopathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
0
num At Risk
542
group Id
EG001
num Affected
1
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Leukocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
0
num At Risk
542
group Id
EG001
num Affected
0
num At Risk
540
group Id
EG002
num Affected
1
num At Risk
93
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
1
num At Risk
542
group Id
EG001
num Affected
1
num At Risk
540
group Id
EG002
num Affected
1
num At Risk
93
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
1
num At Risk
542
group Id
EG001
num Affected
0
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Tachyarrhythmia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
1
num At Risk
542
group Id
EG001
num Affected
0
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Hypoacusis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
1
num At Risk
542
group Id
EG001
num Affected
0
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
0
num At Risk
542
group Id
EG001
num Affected
1
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
1
num At Risk
542
group Id
EG001
num Affected
0
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
2
num At Risk
542
group Id
EG001
num Affected
0
num At Risk
540
group Id
EG002
num Affected
1
num At Risk
93
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 11.0
stats
group Id
EG000
num Affected
1
num At Risk
542
group Id
EG001
num Affected
1
num At Risk
540
group Id
EG002
num Affected
0
num At Risk
93
term
Dyspepsia

time Frame

From first dose of study drug up to 30 days after the last dose of study drug (Approximately 5 years)

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Preserved source evidence · Not medical advice