NCT02032823 · ADVERSE EVENTS

Adverse events

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer · Source last updated 2026-07-14

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 date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
Other-event reporting threshold: 5%

All-Cause Mortality was collected for the Full Analysis Set (FAS). Serious and Other Adverse Events were collected for the Safety Analysis Set (SAS), which includes all participants who received at least 1 dose of randomized study treatment (N=1815). There were 10 patients in the olaparib arm and 11 patients in the placebo arm that did not receive study treatment and therefore are excluded from the SAS. The Other Adverse Events section reports AE's of any grade where the frequency is above 5%.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Olaparib Description (Arm-group)	79 / 911	794 / 911	107 / 921
Placebo Description (Arm-group)	79 / 904	674 / 904	143 / 915

Group identifiers: EG000: Olaparib · EG001: Placebo

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 v27.0
stats
group Id
EG000
num Affected
0
num At Risk
911
num Events
0
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Coronary artery dissection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
2
num At Risk
911
num Events
2
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
911
num Events
0
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Lacunar infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
911
num Events
0
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Ophthalmic migraine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
911
num Events
0
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Sciatica
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
911
num Events
1
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Syncope
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
911
num Events
1
group Id
EG001
num Affected
0
num At Risk
904
num Events
0
term
Vith nerve disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Pregnancy, puerperium and perinatal conditions
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
911
num Events
0
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Abortion spontaneous
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Product Issues
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
911
num Events
1
group Id
EG001
num Affected
0
num At Risk
904
num Events
0
term
Device dislocation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
911
num Events
1
group Id
EG001
num Affected
0
num At Risk
904
num Events
0
term
Bipolar disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
911
num Events
0
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
911
num Events
0
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Suicidal ideation

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
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
86
num At Risk
911
num Events
96
group Id
EG001
num Affected
65
num At Risk
904
num Events
77
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
201
num At Risk
911
num Events
262
group Id
EG001
num Affected
34
num At Risk
904
num Events
39
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
85
num At Risk
911
num Events
90
group Id
EG001
num Affected
80
num At Risk
904
num Events
91
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
160
num At Risk
911
num Events
198
group Id
EG001
num Affected
125
num At Risk
904
num Events
163
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
55
num At Risk
911
num Events
62
group Id
EG001
num Affected
37
num At Risk
904
num Events
39
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
519
num At Risk
911
num Events
684
group Id
EG001
num Affected
213
num At Risk
904
num Events
267
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
81
num At Risk
911
num Events
116
group Id
EG001
num Affected
36
num At Risk
904
num Events
38
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
204
num At Risk
911
num Events
295
group Id
EG001
num Affected
74
num At Risk
904
num Events
84
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
367
num At Risk
911
num Events
444
group Id
EG001
num Affected
248
num At Risk
904
num Events
288
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
58
num At Risk
911
num Events
65
group Id
EG001
num Affected
44
num At Risk
904
num Events
56
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
68
num At Risk
911
num Events
78
group Id
EG001
num Affected
75
num At Risk
904
num Events
84
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
48
num At Risk
911
num Events
57
group Id
EG001
num Affected
40
num At Risk
904
num Events
45
term
Pyrexia

Complete source fields

description

event Groups

deaths Num Affected
107
deaths Num At Risk
921
description
Description (Arm-group)
id
EG000
other Num Affected
794
other Num At Risk
911
serious Num Affected
79
serious Num At Risk
911
title
Olaparib
deaths Num Affected
143
deaths Num At Risk
915
description
Description (Arm-group)
id
EG001
other Num Affected
674
other Num At Risk
904
serious Num Affected
79
serious Num At Risk
904
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
86
num At Risk
911
num Events
96
group Id
EG001
num Affected
65
num At Risk
904
num Events
77
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
201
num At Risk
911
num Events
262
group Id
EG001
num Affected
34
num At Risk
904
num Events
39
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
85
num At Risk
911
num Events
90
group Id
EG001
num Affected
80
num At Risk
904
num Events
91
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
160
num At Risk
911
num Events
198
group Id
EG001
num Affected
125
num At Risk
904
num Events
163
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
55
num At Risk
911
num Events
62
group Id
EG001
num Affected
37
num At Risk
904
num Events
39
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
519
num At Risk
911
num Events
684
group Id
EG001
num Affected
213
num At Risk
904
num Events
267
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
81
num At Risk
911
num Events
116
group Id
EG001
num Affected
36
num At Risk
904
num Events
38
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
204
num At Risk
911
num Events
295
group Id
EG001
num Affected
74
num At Risk
904
num Events
84
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
367
num At Risk
911
num Events
444
group Id
EG001
num Affected
248
num At Risk
904
num Events
288
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
58
num At Risk
911
num Events
65
group Id
EG001
num Affected
44
num At Risk
904
num Events
56
term
Influenza like illness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
68
num At Risk
911
num Events
78
group Id
EG001
num Affected
75
num At Risk
904
num Events
84
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
48
num At Risk
911
num Events
57
group Id
EG001
num Affected
40
num At Risk
904
num Events
45
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
911
num Events
0
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Coronary artery dissection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
2
num At Risk
911
num Events
2
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
911
num Events
0
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Lacunar infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
911
num Events
0
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Ophthalmic migraine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
911
num Events
0
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Sciatica
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
911
num Events
1
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Syncope
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
911
num Events
1
group Id
EG001
num Affected
0
num At Risk
904
num Events
0
term
Vith nerve disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Pregnancy, puerperium and perinatal conditions
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
911
num Events
0
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Abortion spontaneous
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Product Issues
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
911
num Events
1
group Id
EG001
num Affected
0
num At Risk
904
num Events
0
term
Device dislocation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
911
num Events
1
group Id
EG001
num Affected
0
num At Risk
904
num Events
0
term
Bipolar disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
911
num Events
0
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
911
num Events
0
group Id
EG001
num Affected
1
num At Risk
904
num Events
1
term
Suicidal ideation

time Frame

From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)

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

Preserved source evidence · Not medical advice