NCT03732820 · ADVERSE EVENTS

Adverse events

Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer · Source last updated 2026-08-18

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: Adverse events with an onset date, or worsen, on or after the date of first dose and up to and including 30 days following discontinuation of randomised treatment. Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
Other-event reporting threshold: 5%

Adverse events were assessed based on the Safety population consisting of patients who received treatment (N=794) while all-cause mortality was assessed based on all patients randomized (N=796).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Olaparib 300 mg bd + Abiraterone 1000 mg qd Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily	161 / 398	374 / 398	176 / 399
Placebo bd + Abiraterone 1000 mg qd Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.	126 / 396	346 / 396	205 / 397

Group identifiers: EG000: Olaparib 300 mg bd + Abiraterone 1000 mg qd · EG001: Placebo bd + Abiraterone 1000 mg qd

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
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
4
num At Risk
398
num Events
5
group Id
EG001
num Affected
3
num At Risk
396
num Events
3
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
9
num At Risk
398
num Events
17
group Id
EG001
num Affected
3
num At Risk
396
num Events
3
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
398
num Events
0
group Id
EG001
num Affected
1
num At Risk
396
num Events
1
term
Urinary tract infection pseudomonal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
5
num At Risk
398
num Events
5
group Id
EG001
num Affected
2
num At Risk
396
num Events
2
term
Urosepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
398
num Events
1
group Id
EG001
num Affected
0
num At Risk
396
num Events
0
term
Wound infection staphylococcal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
398
num Events
1
group Id
EG001
num Affected
0
num At Risk
396
num Events
0
term
Cervical vertebral fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
398
num Events
1
group Id
EG001
num Affected
0
num At Risk
396
num Events
0
term
Craniocerebral injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
398
num Events
1
group Id
EG001
num Affected
0
num At Risk
396
num Events
0
term
Extra-axial haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
398
num Events
1
group Id
EG001
num Affected
1
num At Risk
396
num Events
1
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
398
num Events
1
group Id
EG001
num Affected
0
num At Risk
396
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
398
num Events
2
group Id
EG001
num Affected
1
num At Risk
396
num Events
1
term
Femoral neck fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
398
num Events
0
group Id
EG001
num Affected
1
num At Risk
396
num Events
1
term
Femur fracture

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
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
21
num At Risk
398
num Events
22
group Id
EG001
num Affected
22
num At Risk
396
num Events
25
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
42
num At Risk
398
num Events
70
group Id
EG001
num Affected
33
num At Risk
396
num Events
41
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
31
num At Risk
398
num Events
36
group Id
EG001
num Affected
19
num At Risk
396
num Events
19
term
Contusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
29
num At Risk
398
num Events
35
group Id
EG001
num Affected
28
num At Risk
396
num Events
35
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
15
num At Risk
398
num Events
19
group Id
EG001
num Affected
27
num At Risk
396
num Events
30
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
16
num At Risk
398
num Events
18
group Id
EG001
num Affected
22
num At Risk
396
num Events
26
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
22
num At Risk
398
num Events
25
group Id
EG001
num Affected
21
num At Risk
396
num Events
24
term
Blood alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
27
num At Risk
398
num Events
52
group Id
EG001
num Affected
19
num At Risk
396
num Events
26
term
Blood creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
34
num At Risk
398
num Events
69
group Id
EG001
num Affected
17
num At Risk
396
num Events
26
term
Lymphocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
27
num At Risk
398
num Events
30
group Id
EG001
num Affected
15
num At Risk
396
num Events
16
term
Weight decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
23
num At Risk
398
num Events
48
group Id
EG001
num Affected
10
num At Risk
396
num Events
13
term
White blood cell count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
66
num At Risk
398
num Events
81
group Id
EG001
num Affected
31
num At Risk
396
num Events
33
term
Decreased appetite

Complete source fields

description

Adverse events were assessed based on the Safety population consisting of patients who received treatment (N=794) while all-cause mortality was assessed based on all patients randomized (N=796).

event Groups

deaths Num Affected
176
deaths Num At Risk
399
description
Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily
id
EG000
other Num Affected
374
other Num At Risk
398
serious Num Affected
161
serious Num At Risk
398
title
Olaparib 300 mg bd + Abiraterone 1000 mg qd
deaths Num Affected
205
deaths Num At Risk
397
description
Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
id
EG001
other Num Affected
346
other Num At Risk
396
serious Num Affected
126
serious Num At Risk
396
title
Placebo bd + Abiraterone 1000 mg qd

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
21
num At Risk
398
num Events
22
group Id
EG001
num Affected
22
num At Risk
396
num Events
25
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
42
num At Risk
398
num Events
70
group Id
EG001
num Affected
33
num At Risk
396
num Events
41
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
31
num At Risk
398
num Events
36
group Id
EG001
num Affected
19
num At Risk
396
num Events
19
term
Contusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
29
num At Risk
398
num Events
35
group Id
EG001
num Affected
28
num At Risk
396
num Events
35
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
15
num At Risk
398
num Events
19
group Id
EG001
num Affected
27
num At Risk
396
num Events
30
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
16
num At Risk
398
num Events
18
group Id
EG001
num Affected
22
num At Risk
396
num Events
26
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
22
num At Risk
398
num Events
25
group Id
EG001
num Affected
21
num At Risk
396
num Events
24
term
Blood alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
27
num At Risk
398
num Events
52
group Id
EG001
num Affected
19
num At Risk
396
num Events
26
term
Blood creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
34
num At Risk
398
num Events
69
group Id
EG001
num Affected
17
num At Risk
396
num Events
26
term
Lymphocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
27
num At Risk
398
num Events
30
group Id
EG001
num Affected
15
num At Risk
396
num Events
16
term
Weight decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
23
num At Risk
398
num Events
48
group Id
EG001
num Affected
10
num At Risk
396
num Events
13
term
White blood cell count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
66
num At Risk
398
num Events
81
group Id
EG001
num Affected
31
num At Risk
396
num Events
33
term
Decreased appetite

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
4
num At Risk
398
num Events
5
group Id
EG001
num Affected
3
num At Risk
396
num Events
3
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
9
num At Risk
398
num Events
17
group Id
EG001
num Affected
3
num At Risk
396
num Events
3
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
398
num Events
0
group Id
EG001
num Affected
1
num At Risk
396
num Events
1
term
Urinary tract infection pseudomonal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
5
num At Risk
398
num Events
5
group Id
EG001
num Affected
2
num At Risk
396
num Events
2
term
Urosepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
398
num Events
1
group Id
EG001
num Affected
0
num At Risk
396
num Events
0
term
Wound infection staphylococcal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
398
num Events
1
group Id
EG001
num Affected
0
num At Risk
396
num Events
0
term
Cervical vertebral fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
398
num Events
1
group Id
EG001
num Affected
0
num At Risk
396
num Events
0
term
Craniocerebral injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
398
num Events
1
group Id
EG001
num Affected
0
num At Risk
396
num Events
0
term
Extra-axial haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
398
num Events
1
group Id
EG001
num Affected
1
num At Risk
396
num Events
1
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
1
num At Risk
398
num Events
1
group Id
EG001
num Affected
0
num At Risk
396
num Events
0
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
2
num At Risk
398
num Events
2
group Id
EG001
num Affected
1
num At Risk
396
num Events
1
term
Femoral neck fracture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.0
stats
group Id
EG000
num Affected
0
num At Risk
398
num Events
0
group Id
EG001
num Affected
1
num At Risk
396
num Events
1
term
Femur fracture

time Frame

Adverse events with an onset date, or worsen, on or after the date of first dose and up to and including 30 days following discontinuation of randomised treatment. Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)

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

Preserved source evidence · Not medical advice