NCT02987543 · ADVERSE EVENTS

Adverse events

Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study) · Source last updated 2023-10-06

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 the time of signature of informed consent throughout the treatment period (median duration of treatment of 7.5 and 3.9 months for Olaparib and Investigators Choice of NHA respectively) up to and including the 30-day follow-up period
Other-event reporting threshold: 5%

There were 131 subjects randomised to the Investigators Choice of NHA treatment group (Full Analysis Set), however 1 of these subjects did not receive treatment (resulting in 130 in the Safety Analysis Set). Hence, for the Investigators Choice of NHA, the Total number at risk for all-cause mortality = 131 while the Total # at Risk by any Serious Adverse Event = 130 and the Total # at Risk by any Other Adverse Event = 130.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort A+B Olaparib 300mg bd 2x150mg film-coated tablets	94 / 256	241 / 256	160 / 256
Cohort A+B Investigators Choice of NHA either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)	39 / 130	112 / 130	88 / 131

Group identifiers: EG000: Cohort A+B Olaparib 300mg bd · EG001: Cohort A+B Investigators Choice of NHA

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 22.0
stats
group Id
EG000
num Affected
23
num At Risk
256
num Events
24
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
1
num At Risk
130
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
3
num At Risk
256
num Events
3
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
4
num At Risk
256
num Events
6
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
2
num At Risk
130
num Events
2
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
1
num At Risk
130
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Cardiac failure acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
1
num At Risk
130
num Events
1
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
2
num At Risk
256
num Events
2
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Cardiopulmonary failure

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 22.0
stats
group Id
EG000
num Affected
110
num At Risk
256
num Events
154
group Id
EG001
num Affected
20
num At Risk
130
num Events
23
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
49
num At Risk
256
num Events
52
group Id
EG001
num Affected
19
num At Risk
130
num Events
21
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
54
num At Risk
256
num Events
71
group Id
EG001
num Affected
9
num At Risk
130
num Events
9
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
20
num At Risk
256
num Events
23
group Id
EG001
num Affected
3
num At Risk
130
num Events
3
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
109
num At Risk
256
num Events
136
group Id
EG001
num Affected
26
num At Risk
130
num Events
28
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
49
num At Risk
256
num Events
82
group Id
EG001
num Affected
17
num At Risk
130
num Events
19
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
37
num At Risk
256
num Events
54
group Id
EG001
num Affected
18
num At Risk
130
num Events
19
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
68
num At Risk
256
num Events
71
group Id
EG001
num Affected
28
num At Risk
130
num Events
28
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
34
num At Risk
256
num Events
36
group Id
EG001
num Affected
10
num At Risk
130
num Events
10
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
15
num At Risk
256
num Events
16
group Id
EG001
num Affected
4
num At Risk
130
num Events
4
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
18
num At Risk
256
num Events
22
group Id
EG001
num Affected
12
num At Risk
130
num Events
15
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
21
num At Risk
256
num Events
21
group Id
EG001
num Affected
7
num At Risk
130
num Events
7
term
Weight decreased

Complete source fields

description

event Groups

deaths Num Affected
160
deaths Num At Risk
256
description
2x150mg film-coated tablets
id
EG000
other Num Affected
241
other Num At Risk
256
serious Num Affected
94
serious Num At Risk
256
title
Cohort A+B Olaparib 300mg bd
deaths Num Affected
88
deaths Num At Risk
131
description
either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
id
EG001
other Num Affected
112
other Num At Risk
130
serious Num Affected
39
serious Num At Risk
130
title
Cohort A+B Investigators Choice of NHA

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
110
num At Risk
256
num Events
154
group Id
EG001
num Affected
20
num At Risk
130
num Events
23
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
49
num At Risk
256
num Events
52
group Id
EG001
num Affected
19
num At Risk
130
num Events
21
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
54
num At Risk
256
num Events
71
group Id
EG001
num Affected
9
num At Risk
130
num Events
9
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
20
num At Risk
256
num Events
23
group Id
EG001
num Affected
3
num At Risk
130
num Events
3
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
109
num At Risk
256
num Events
136
group Id
EG001
num Affected
26
num At Risk
130
num Events
28
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
49
num At Risk
256
num Events
82
group Id
EG001
num Affected
17
num At Risk
130
num Events
19
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
37
num At Risk
256
num Events
54
group Id
EG001
num Affected
18
num At Risk
130
num Events
19
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
68
num At Risk
256
num Events
71
group Id
EG001
num Affected
28
num At Risk
130
num Events
28
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
34
num At Risk
256
num Events
36
group Id
EG001
num Affected
10
num At Risk
130
num Events
10
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
15
num At Risk
256
num Events
16
group Id
EG001
num Affected
4
num At Risk
130
num Events
4
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
18
num At Risk
256
num Events
22
group Id
EG001
num Affected
12
num At Risk
130
num Events
15
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
21
num At Risk
256
num Events
21
group Id
EG001
num Affected
7
num At Risk
130
num Events
7
term
Weight decreased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
23
num At Risk
256
num Events
24
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
1
num At Risk
130
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
3
num At Risk
256
num Events
3
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
4
num At Risk
256
num Events
6
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Acute coronary syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
2
num At Risk
130
num Events
2
term
Angina pectoris
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
1
num At Risk
130
num Events
1
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
1
num At Risk
256
num Events
1
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Cardiac failure acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
0
num At Risk
256
num Events
0
group Id
EG001
num Affected
1
num At Risk
130
num Events
1
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 22.0
stats
group Id
EG000
num Affected
2
num At Risk
256
num Events
2
group Id
EG001
num Affected
0
num At Risk
130
num Events
0
term
Cardiopulmonary failure

time Frame

From the time of signature of informed consent throughout the treatment period (median duration of treatment of 7.5 and 3.9 months for Olaparib and Investigators Choice of NHA respectively) up to and including the 30-day follow-up period

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Preserved source evidence · Not medical advice