Trial Outcomes & Findings for Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (NCT NCT02032823)
NCT ID: NCT02032823
Last Updated: 2026-02-17
Results Overview
An IDFS event is defined as the first occurrence of loco-regional or distant recurrence or new cancer or death from any cause.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
1836 participants
Primary outcome timeframe
From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)
Results posted on
2026-02-17
Participant Flow
The first patient was enrolled on 22 April 2014. Patients were randomised from 554 centres in 23 countries worldwide.
Patients with unknown germline BRCA (gBRCA) mutation status prior to randomisation underwent Screening Part 1 to ascertain gBRCA mutation status during, or prior to, neoadjuvant/adjuvant chemotherapy. All patients with known gBRCA mutation status (including those found through Screening Part 1) underwent Screening Part 2.
Participant milestones
| Measure |
Olaparib
Olaparib tablets 300mg taken orally twice daily.
|
Placebo
Placebo tablets taken orally twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
921
|
915
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
921
|
915
|
Reasons for withdrawal
| Measure |
Olaparib
Olaparib tablets 300mg taken orally twice daily.
|
Placebo
Placebo tablets taken orally twice daily.
|
|---|---|---|
|
Overall Study
Death
|
107
|
143
|
|
Overall Study
Lost to Follow-up
|
36
|
36
|
|
Overall Study
Withdrawal by Subject
|
78
|
64
|
|
Overall Study
Ongoing study at the data cut-off (DCO3: 05Jun2024)
|
697
|
666
|
|
Overall Study
Other (e.g investigators decision, protocol deviation, randomised by mistake)
|
3
|
6
|
Baseline Characteristics
Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
Baseline characteristics by cohort
| Measure |
Olaparib
n=921 Participants
Olaparib tablets 300mg taken orally twice daily.
|
Placebo
n=915 Participants
Placebo tablets taken orally twice daily.
|
Total
n=1836 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.0 Years
STANDARD_DEVIATION 9.8 • n=25 Participants
|
43.6 Years
STANDARD_DEVIATION 10.1 • n=20 Participants
|
43.3 Years
STANDARD_DEVIATION 10.0 • n=45 Participants
|
|
Age, Customized
<30 years
|
51 Participants
n=25 Participants
|
59 Participants
n=20 Participants
|
110 Participants
n=45 Participants
|
|
Age, Customized
30-39 years
|
333 Participants
n=25 Participants
|
306 Participants
n=20 Participants
|
639 Participants
n=45 Participants
|
|
Age, Customized
40-49 years
|
315 Participants
n=25 Participants
|
308 Participants
n=20 Participants
|
623 Participants
n=45 Participants
|
|
Age, Customized
50-59 years
|
166 Participants
n=25 Participants
|
172 Participants
n=20 Participants
|
338 Participants
n=45 Participants
|
|
Age, Customized
60-69 years
|
48 Participants
n=25 Participants
|
66 Participants
n=20 Participants
|
114 Participants
n=45 Participants
|
|
Age, Customized
>=70 years
|
8 Participants
n=25 Participants
|
4 Participants
n=20 Participants
|
12 Participants
n=45 Participants
|
|
Sex: Female, Male
Female
|
919 Participants
n=25 Participants
|
911 Participants
n=20 Participants
|
1830 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=25 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
HISPANIC OR LATINO
|
34 Participants
n=25 Participants
|
24 Participants
n=20 Participants
|
58 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
NOT HISPANIC OR LATINO
|
805 Participants
n=25 Participants
|
812 Participants
n=20 Participants
|
1617 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
NOT KNOWN, NOT RECORDED, OR REFUSED
|
82 Participants
n=25 Participants
|
79 Participants
n=20 Participants
|
161 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
3 Participants
n=25 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
259 Participants
n=25 Participants
|
272 Participants
n=20 Participants
|
531 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
19 Participants
n=25 Participants
|
29 Participants
n=20 Participants
|
48 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
|
1 Participants
n=25 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
626 Participants
n=25 Participants
|
599 Participants
n=20 Participants
|
1225 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
3 Participants
n=25 Participants
|
6 Participants
n=20 Participants
|
9 Participants
n=45 Participants
|
|
Race/Ethnicity, Customized
MISSING
|
10 Participants
n=25 Participants
|
8 Participants
n=20 Participants
|
18 Participants
n=45 Participants
|
|
Region of Enrollment
ARG
|
16 Participants
n=25 Participants
|
12 Participants
n=20 Participants
|
28 Participants
n=45 Participants
|
|
Region of Enrollment
AUS
|
30 Participants
n=25 Participants
|
30 Participants
n=20 Participants
|
60 Participants
n=45 Participants
|
|
Region of Enrollment
AUT
|
28 Participants
n=25 Participants
|
25 Participants
n=20 Participants
|
53 Participants
n=45 Participants
|
|
Region of Enrollment
BEL
|
12 Participants
n=25 Participants
|
26 Participants
n=20 Participants
|
38 Participants
n=45 Participants
|
|
Region of Enrollment
CAN
|
11 Participants
n=25 Participants
|
23 Participants
n=20 Participants
|
34 Participants
n=45 Participants
|
|
Region of Enrollment
CHE
|
4 Participants
n=25 Participants
|
17 Participants
n=20 Participants
|
21 Participants
n=45 Participants
|
|
Region of Enrollment
CHN
|
117 Participants
n=25 Participants
|
130 Participants
n=20 Participants
|
247 Participants
n=45 Participants
|
|
Region of Enrollment
DEU
|
106 Participants
n=25 Participants
|
92 Participants
n=20 Participants
|
198 Participants
n=45 Participants
|
|
Region of Enrollment
ESP
|
63 Participants
n=25 Participants
|
46 Participants
n=20 Participants
|
109 Participants
n=45 Participants
|
|
Region of Enrollment
FRA
|
77 Participants
n=25 Participants
|
65 Participants
n=20 Participants
|
142 Participants
n=45 Participants
|
|
Region of Enrollment
GBR
|
60 Participants
n=25 Participants
|
46 Participants
n=20 Participants
|
106 Participants
n=45 Participants
|
|
Region of Enrollment
HUN
|
8 Participants
n=25 Participants
|
9 Participants
n=20 Participants
|
17 Participants
n=45 Participants
|
|
Region of Enrollment
ISL
|
5 Participants
n=25 Participants
|
1 Participants
n=20 Participants
|
6 Participants
n=45 Participants
|
|
Region of Enrollment
ISR
|
30 Participants
n=25 Participants
|
35 Participants
n=20 Participants
|
65 Participants
n=45 Participants
|
|
Region of Enrollment
ITA
|
30 Participants
n=25 Participants
|
27 Participants
n=20 Participants
|
57 Participants
n=45 Participants
|
|
Region of Enrollment
JPN
|
64 Participants
n=25 Participants
|
76 Participants
n=20 Participants
|
140 Participants
n=45 Participants
|
|
Region of Enrollment
KOR
|
53 Participants
n=25 Participants
|
44 Participants
n=20 Participants
|
97 Participants
n=45 Participants
|
|
Region of Enrollment
NLD
|
11 Participants
n=25 Participants
|
18 Participants
n=20 Participants
|
29 Participants
n=45 Participants
|
|
Region of Enrollment
POL
|
50 Participants
n=25 Participants
|
59 Participants
n=20 Participants
|
109 Participants
n=45 Participants
|
|
Region of Enrollment
PRT
|
7 Participants
n=25 Participants
|
6 Participants
n=20 Participants
|
13 Participants
n=45 Participants
|
|
Region of Enrollment
SWE
|
20 Participants
n=25 Participants
|
15 Participants
n=20 Participants
|
35 Participants
n=45 Participants
|
|
Region of Enrollment
TWN
|
8 Participants
n=25 Participants
|
4 Participants
n=20 Participants
|
12 Participants
n=45 Participants
|
|
Region of Enrollment
USA
|
111 Participants
n=25 Participants
|
109 Participants
n=20 Participants
|
220 Participants
n=45 Participants
|
PRIMARY outcome
Timeframe: From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)Population: Full Analysis Set (FAS)
An IDFS event is defined as the first occurrence of loco-regional or distant recurrence or new cancer or death from any cause.
Outcome measures
| Measure |
Olaparib
n=921 Participants
Olaparib tablets 300mg taken orally twice daily.
|
Placebo
n=915 Participants
Placebo tablets taken orally twice daily.
|
|---|---|---|
|
Invasive Disease Free Survival (IDFS)
|
106 Participants
|
178 Participants
|
SECONDARY outcome
Timeframe: From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)Population: Full Analysis Set (FAS)
A DDFS event is defined as documented evidence of first distant recurrence of breast cancer or death from any cause
Outcome measures
| Measure |
Olaparib
n=921 Participants
Olaparib tablets 300mg taken orally twice daily.
|
Placebo
n=915 Participants
Placebo tablets taken orally twice daily.
|
|---|---|---|
|
Distant Disease Free Survival (DDFS)
|
89 Participants
|
152 Participants
|
SECONDARY outcome
Timeframe: From date of randomisation to data cut off: 12 July 2021 (approximately 7 years 3 months)Population: Full Analysis Set (FAS)
An OS event is defined as death by any cause.
Outcome measures
| Measure |
Olaparib
n=921 Participants
Olaparib tablets 300mg taken orally twice daily.
|
Placebo
n=915 Participants
Placebo tablets taken orally twice daily.
|
|---|---|---|
|
Overall Survival (OS)
|
75 Participants
|
109 Participants
|
SECONDARY outcome
Timeframe: From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)Population: Full Analysis Set (FAS)
Number of patients with contralateral invasive breast cancer, contralateral non-invasive breast cancer, new primary ovarian cancer, new primary fallopian tube cancer and new primary peritoneal cancer. Analysis of contralateral breast cancers exclude patients with a bilateral mastectomy prior to randomisation. Analysis of new primary ovarian cancers excludes male patients and patients with a bilateral oophorectomy prior to randomisation. Analysis of new primary fallopian tube cancer excludes male patients and patients with a bilateral salpingectomy prior to randomisation. Analysis of new primary peritoneal cancers excludes male patients.
Outcome measures
| Measure |
Olaparib
n=921 Participants
Olaparib tablets 300mg taken orally twice daily.
|
Placebo
n=915 Participants
Placebo tablets taken orally twice daily.
|
|---|---|---|
|
Number of Participants With Contralateral Invasive and Non-invasive Breast Cancer, New Primary Ovarian Cancer, New Primary Fallopian Tube Cancer and New Primary Peritoneal Cancer
Contralateral invasive breast cancer
|
31 Participants
|
40 Participants
|
|
Number of Participants With Contralateral Invasive and Non-invasive Breast Cancer, New Primary Ovarian Cancer, New Primary Fallopian Tube Cancer and New Primary Peritoneal Cancer
Contralateral non-invasive breast cancer
|
3 Participants
|
4 Participants
|
|
Number of Participants With Contralateral Invasive and Non-invasive Breast Cancer, New Primary Ovarian Cancer, New Primary Fallopian Tube Cancer and New Primary Peritoneal Cancer
New primary ovarian cancer
|
3 Participants
|
9 Participants
|
|
Number of Participants With Contralateral Invasive and Non-invasive Breast Cancer, New Primary Ovarian Cancer, New Primary Fallopian Tube Cancer and New Primary Peritoneal Cancer
New primary fallopian tube cancer
|
1 Participants
|
4 Participants
|
|
Number of Participants With Contralateral Invasive and Non-invasive Breast Cancer, New Primary Ovarian Cancer, New Primary Fallopian Tube Cancer and New Primary Peritoneal Cancer
New primary peritoneal cancer
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)Population: Patient reported outcomes (PRO) Analysis Set
Change from baseline for FACIT-Fatigue Score at 6, 12, 18 and 24 months for patients who completed neoadjuvant chemotherapy. Adjusted least-square mean changes and 95% Confidence Interval (CI) are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. FACIT-Fatigue score ranges from 0 to 52 with higher score indicating less fatigue.
Outcome measures
| Measure |
Olaparib
n=382 Participants
Olaparib tablets 300mg taken orally twice daily.
|
Placebo
n=359 Participants
Placebo tablets taken orally twice daily.
|
|---|---|---|
|
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy
Change from baseline FACIT-Fatigue Score to 6 months
|
-1.5 Scores on a scale
Interval -2.3 to -0.8
|
-0.2 Scores on a scale
Interval -1.0 to 0.6
|
|
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy
Change from baseline FACIT-Fatigue Score to 12 months
|
-1.5 Scores on a scale
Interval -2.4 to -0.6
|
0.0 Scores on a scale
Interval -0.9 to 0.9
|
|
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy
Change from baseline FACIT-Fatigue Score to 18 months
|
1.3 Scores on a scale
Interval 0.4 to 2.2
|
1.4 Scores on a scale
Interval 0.5 to 2.3
|
|
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy
Change from baseline FACIT-Fatigue Score to 24 months
|
1.6 Scores on a scale
Interval 0.7 to 2.4
|
2.0 Scores on a scale
Interval 1.1 to 2.9
|
SECONDARY outcome
Timeframe: 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)Population: Patient reported outcomes (PRO) Analysis Set
Change from baseline for FACIT-Fatigue Score at 6, 12, 18 and 24 months for patients who completed adjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. FACIT-Fatigue score ranges from 0 to 52 with higher score indicating less fatigue.
Outcome measures
| Measure |
Olaparib
n=382 Participants
Olaparib tablets 300mg taken orally twice daily.
|
Placebo
n=406 Participants
Placebo tablets taken orally twice daily.
|
|---|---|---|
|
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy
Change from baseline FACIT-Fatigue Score to 6 months
|
-0.7 Scores on a scale
Interval -1.5 to 0.0
|
0.6 Scores on a scale
Interval -0.2 to 1.3
|
|
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy
Change from baseline FACIT-Fatigue Score to 12 months
|
-0.8 Scores on a scale
Interval -1.6 to 0.0
|
0.5 Scores on a scale
Interval -0.3 to 1.2
|
|
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy
Change from baseline FACIT-Fatigue Score to 18 months
|
0.9 Scores on a scale
Interval 0.1 to 1.7
|
1.2 Scores on a scale
Interval 0.4 to 2.0
|
|
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Adjuvant Chemotherapy
Change from baseline FACIT-Fatigue Score to 24 months
|
1.3 Scores on a scale
Interval 0.5 to 2.1
|
1.6 Scores on a scale
Interval 0.7 to 2.4
|
SECONDARY outcome
Timeframe: 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)Population: Patient reported outcomes (PRO) Analysis Set
Change from baseline for EORTC QLQ-C30 Global health status QOL (Quality of Life) Score at 6, 12, 18 and 24 months for patients who completed neoadjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. EORTC QLQ-C30 scores range from 0 to 100 with higher score indicating better quality of life.
Outcome measures
| Measure |
Olaparib
n=382 Participants
Olaparib tablets 300mg taken orally twice daily.
|
Placebo
n=358 Participants
Placebo tablets taken orally twice daily.
|
|---|---|---|
|
Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Neoadjuvant Chemotherapy
Change from baseline EORTC QLQ-C30 Global health status score to 6 months
|
-0.4 Scores on a scale
Interval -2.2 to 1.4
|
0.4 Scores on a scale
Interval -1.4 to 2.2
|
|
Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Neoadjuvant Chemotherapy
Change from baseline EORTC QLQ-C30 Global health status score to 12 months
|
0.5 Scores on a scale
Interval -1.5 to 2.4
|
2.7 Scores on a scale
Interval 0.7 to 4.7
|
|
Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Neoadjuvant Chemotherapy
Change from baseline EORTC QLQ-C30 Global health status score to 18 months
|
3.3 Scores on a scale
Interval 1.3 to 5.3
|
4.4 Scores on a scale
Interval 2.3 to 6.4
|
|
Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Neoadjuvant Chemotherapy
Change from baseline EORTC QLQ-C30 Global health status score to 24 months
|
2.8 Scores on a scale
Interval 0.6 to 5.0
|
6.1 Scores on a scale
Interval 3.8 to 8.4
|
SECONDARY outcome
Timeframe: 6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)Population: Patient reported outcomes (PRO) Analysis Set
Change from baseline for EORTC QLQ-C30 Global health status QOL (Quality of Life) Score at 6, 12, 18 and 24 months for patients who completed adjuvant chemotherapy. Adjusted least-square mean changes and 95% CI are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. EORTC QLQ-C30 scores range from 0 to 100 with higher score indicating better quality of life.
Outcome measures
| Measure |
Olaparib
n=383 Participants
Olaparib tablets 300mg taken orally twice daily.
|
Placebo
n=407 Participants
Placebo tablets taken orally twice daily.
|
|---|---|---|
|
Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Adjuvant Chemotherapy
Change from baseline EORTC QLQ-C30 Global health status score to 6 months
|
-0.5 Scores on a scale
Interval -2.2 to 1.2
|
2.2 Scores on a scale
Interval 0.6 to 3.8
|
|
Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Adjuvant Chemotherapy
Change from baseline EORTC QLQ-C30 Global health status score to 12 months
|
0.6 Scores on a scale
Interval -1.1 to 2.4
|
3.1 Scores on a scale
Interval 1.5 to 4.8
|
|
Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Adjuvant Chemotherapy
Change from baseline EORTC QLQ-C30 Global health status score to 18 months
|
2.9 Scores on a scale
Interval 1.1 to 4.7
|
5.1 Scores on a scale
Interval 3.3 to 6.9
|
|
Change From Baseline for EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questions 30) Scores for Participants Who Completed Adjuvant Chemotherapy
Change from baseline EORTC QLQ-C30 Global health status score to 24 months
|
4.5 Scores on a scale
Interval 2.6 to 6.4
|
4.8 Scores on a scale
Interval 2.9 to 6.7
|
Adverse Events
Olaparib
Serious events: 79 serious events
Other events: 794 other events
Deaths: 107 deaths
Placebo
Serious events: 79 serious events
Other events: 674 other events
Deaths: 143 deaths
Serious adverse events
| Measure |
Olaparib
n=911 participants at risk
Description (Arm-group)
|
Placebo
n=904 participants at risk
Description (Arm-group)
|
|---|---|---|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Nervous system disorders
Headache
|
0.22%
2/911 • Number of events 2 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Nervous system disorders
Ophthalmic migraine
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Nervous system disorders
Syncope
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Nervous system disorders
Vith nerve disorder
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Product Issues
Device dislocation
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Psychiatric disorders
Bipolar disorder
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Psychiatric disorders
Suicide attempt
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Renal and urinary disorders
Bladder disorder
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Reproductive system and breast disorders
Breast disorder
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Reproductive system and breast disorders
Breast fibrosis
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Cardiac disorders
Pericardial effusion
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Reproductive system and breast disorders
Ovarian haemorrhage
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.22%
2/911 • Number of events 2 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.22%
2/911 • Number of events 2 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Surgical and medical procedures
Oophorectomy
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Endocrine disorders
Hypothyroidism
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Eye disorders
Vision blurred
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.33%
3/904 • Number of events 3 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Colitis
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
15/911 • Number of events 17 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Intestinal prolapse
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Nausea
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Vomiting
|
0.22%
2/911 • Number of events 2 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.33%
3/911 • Number of events 3 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
General disorders
Chest pain
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
General disorders
Fatigue
|
0.11%
1/911 • Number of events 5 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
General disorders
Foreign body reaction
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
General disorders
Impaired healing
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
General disorders
Non-cardiac chest pain
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
General disorders
Pyrexia
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.33%
3/904 • Number of events 3 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Immune system disorders
Anaphylactic reaction
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Appendicitis
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Bronchitis
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Cellulitis
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.22%
2/904 • Number of events 3 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Cystitis
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Device related infection
|
0.33%
3/911 • Number of events 3 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.22%
2/904 • Number of events 2 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Gastroenteritis
|
0.22%
2/911 • Number of events 2 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Gingivitis
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Cardiac disorders
Angina pectoris
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Influenza
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Mastitis
|
0.33%
3/911 • Number of events 3 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.66%
6/904 • Number of events 6 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Pneumonia
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Urinary tract infection
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Wound infection
|
0.22%
2/911 • Number of events 2 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 2 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Cardiac disorders
Cardiac arrest
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Injury, poisoning and procedural complications
Ureteric injury
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.44%
4/904 • Number of events 4 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 3 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Cardiac disorders
Cardiac failure
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Investigations
Neutrophil count decreased
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Investigations
Platelet count decreased
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.22%
2/911 • Number of events 2 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Musculoskeletal and connective tissue disorders
Chest wall mass
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.33%
3/904 • Number of events 3 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.22%
2/904 • Number of events 2 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chest wall tumour
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fallopian tube cancer
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.22%
2/904 • Number of events 2 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fallopian tube cancer stage i
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Cardiac disorders
Coronary artery disease
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.44%
4/904 • Number of events 4 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.44%
4/904 • Number of events 4 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Nervous system disorders
Ataxia
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Nervous system disorders
Cognitive disorder
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Psychiatric disorders
Depression
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.22%
2/904 • Number of events 2 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Vascular disorders
Embolism
|
0.22%
2/911 • Number of events 2 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Vascular disorders
Lymphoedema
|
0.11%
1/911 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.00%
0/904 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/911 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
0.11%
1/904 • Number of events 1 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
Other adverse events
| Measure |
Olaparib
n=911 participants at risk
Description (Arm-group)
|
Placebo
n=904 participants at risk
Description (Arm-group)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
9.4%
86/911 • Number of events 96 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
7.2%
65/904 • Number of events 77 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Blood and lymphatic system disorders
Anaemia
|
22.1%
201/911 • Number of events 262 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
3.8%
34/904 • Number of events 39 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Constipation
|
9.3%
85/911 • Number of events 90 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
8.8%
80/904 • Number of events 91 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.6%
160/911 • Number of events 198 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
13.8%
125/904 • Number of events 163 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.0%
55/911 • Number of events 62 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
4.1%
37/904 • Number of events 39 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Nausea
|
57.0%
519/911 • Number of events 684 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
23.6%
213/904 • Number of events 267 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Stomatitis
|
8.9%
81/911 • Number of events 116 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
4.0%
36/904 • Number of events 38 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Gastrointestinal disorders
Vomiting
|
22.4%
204/911 • Number of events 295 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
8.2%
74/904 • Number of events 84 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
General disorders
Fatigue
|
40.3%
367/911 • Number of events 444 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
27.4%
248/904 • Number of events 288 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
General disorders
Influenza like illness
|
6.4%
58/911 • Number of events 65 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
4.9%
44/904 • Number of events 56 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
General disorders
Pain
|
7.5%
68/911 • Number of events 78 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
8.3%
75/904 • Number of events 84 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
General disorders
Pyrexia
|
5.3%
48/911 • Number of events 57 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
4.4%
40/904 • Number of events 45 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
31/911 • Number of events 45 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
5.8%
52/904 • Number of events 74 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.7%
79/911 • Number of events 92 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
8.3%
75/904 • Number of events 105 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Investigations
Lymphocyte count decreased
|
6.8%
62/911 • Number of events 88 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
1.7%
15/904 • Number of events 16 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Investigations
Neutrophil count decreased
|
16.2%
148/911 • Number of events 213 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
6.5%
59/904 • Number of events 82 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Investigations
White blood cell count decreased
|
15.9%
145/911 • Number of events 218 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
5.9%
53/904 • Number of events 71 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.2%
120/911 • Number of events 136 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
5.9%
53/904 • Number of events 55 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
88/911 • Number of events 94 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
12.6%
114/904 • Number of events 126 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
59/911 • Number of events 64 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
8.0%
72/904 • Number of events 76 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.5%
50/911 • Number of events 58 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
5.5%
50/904 • Number of events 51 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.8%
62/911 • Number of events 74 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
7.1%
64/904 • Number of events 70 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Nervous system disorders
Dizziness
|
11.3%
103/911 • Number of events 112 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
7.4%
67/904 • Number of events 73 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Nervous system disorders
Dysgeusia
|
11.7%
107/911 • Number of events 125 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
4.3%
39/904 • Number of events 42 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Nervous system disorders
Headache
|
19.5%
178/911 • Number of events 217 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
16.7%
151/904 • Number of events 196 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Psychiatric disorders
Insomnia
|
7.4%
67/911 • Number of events 71 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
6.7%
61/904 • Number of events 65 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
77/911 • Number of events 85 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
8.0%
72/904 • Number of events 80 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
|
Vascular disorders
Hot flush
|
8.0%
73/911 • Number of events 76 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
8.2%
74/904 • Number of events 76 • From date of randomisation to data cut off: 05 June 2024 (approximately 10 years 2 months)
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%.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Restrictions are imposed by the trial's Steering Committee (SC) and intend to ensure that all publications/presentations are peer reviewed by the SC. Sponsor has the right to review/comment on the content of the material to be published/presented, may request removal of confidential information (e.g. patentable information/trade secrets) within max 90 days. Individual Institutions may publish/present data from their site(s) in compliance with conditions defined in Study Publication Policy.
- Publication restrictions are in place
Restriction type: OTHER