Trial Outcomes & Findings for Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer (NCT NCT04269200)
NCT ID: NCT04269200
Last Updated: 2025-12-23
Results Overview
To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 \[RECIST 1.1\]) in patients with newly diagnosed advanced or recurrent endometrial cancer
ACTIVE_NOT_RECRUITING
PHASE3
805 participants
At baseline, every 9 weeks (wks) up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 months
2025-12-23
Participant Flow
Global Cohort: 875 patients screened across 179 centres in 22 countries; 718 were randomised. Results were reported for analysis of progression-free survival (PFS) (data cut-off \[DCO\]: 12 Apr 2023). China Cohort: 172 patients screened across 25 sites; 129 were randomized. Results were reported for analysis of PFS (DCO: 08 Jul 2024). In total, 805 patients were randomised; 718 to the Global cohort, 129 to the China cohort, with 42 patients overlapping and belonging to both cohorts.
It was planned that approximately 699 women from the Global cohort and 129 women from the China cohort, with newly diagnosed advanced or recurrent endometrial cancer, were to receive durvalumab/placebo in combination with platinum-based chemotherapy followed by maintenance durvalumab/placebo (same treatment as during chemotherapy phase) and olaparib/placebo in a 1:1:1 ratio.
Participant milestones
| Measure |
SoC + Durvalumab
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
SoC + Durvalumab + Olaparib
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
Standard of Care (SoC)
Platinum-based chemotherapy (paclitaxel and carboplatin) every 3 weeks (Q3W) for a maximum of 6 cycles with durvalumab placebo (intravenous \[IV\]) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) every 4 weeks (Q4W) and olaparib placebo (tablets) twice daily (bd) orally as maintenance treatment until disease progression.
|
|---|---|---|---|
|
Global Cohort
STARTED
|
238
|
239
|
241
|
|
Global Cohort
COMPLETED
|
159
|
170
|
147
|
|
Global Cohort
NOT COMPLETED
|
79
|
69
|
94
|
|
China Cohort
STARTED
|
43
|
42
|
44
|
|
China Cohort
COMPLETED
|
29
|
24
|
30
|
|
China Cohort
NOT COMPLETED
|
14
|
18
|
14
|
Reasons for withdrawal
| Measure |
SoC + Durvalumab
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
SoC + Durvalumab + Olaparib
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
Standard of Care (SoC)
Platinum-based chemotherapy (paclitaxel and carboplatin) every 3 weeks (Q3W) for a maximum of 6 cycles with durvalumab placebo (intravenous \[IV\]) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) every 4 weeks (Q4W) and olaparib placebo (tablets) twice daily (bd) orally as maintenance treatment until disease progression.
|
|---|---|---|---|
|
Global Cohort
Death
|
54
|
49
|
72
|
|
Global Cohort
Lost to Follow-up
|
0
|
2
|
0
|
|
Global Cohort
Withdrawal by Subject
|
25
|
18
|
22
|
|
China Cohort
Death
|
11
|
13
|
12
|
|
China Cohort
Lost to Follow-up
|
1
|
1
|
0
|
|
China Cohort
Withdrawal by Subject
|
2
|
4
|
2
|
Baseline Characteristics
The results are presented by Global cohort and by China cohort.
Baseline characteristics by cohort
| Measure |
SoC (Global Cohort & China Cohort)
n=270 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
SoC + Durvalumab (Global Cohort & China Cohort)
n=267 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
SoC + Durvalumab + Olaparib (Global Cohort & China Cohort)
n=268 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
Total
n=805 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
Global cohort
|
62.1 Years
STANDARD_DEVIATION 10.36 • n=241 Participants • The results are presented by Global cohort and by China cohort.
|
63.3 Years
STANDARD_DEVIATION 9.82 • n=238 Participants • The results are presented by Global cohort and by China cohort.
|
62.4 Years
STANDARD_DEVIATION 9.90 • n=239 Participants • The results are presented by Global cohort and by China cohort.
|
62.6 Years
STANDARD_DEVIATION 10.03 • n=718 Participants • The results are presented by Global cohort and by China cohort.
|
|
Age, Continuous
China cohort
|
58.3 Years
STANDARD_DEVIATION 8.73 • n=44 Participants • The results are presented by Global cohort and by China cohort.
|
57.6 Years
STANDARD_DEVIATION 10.57 • n=43 Participants • The results are presented by Global cohort and by China cohort.
|
59.3 Years
STANDARD_DEVIATION 8.41 • n=42 Participants • The results are presented by Global cohort and by China cohort.
|
58.4 Years
STANDARD_DEVIATION 9.24 • n=129 Participants • The results are presented by Global cohort and by China cohort.
|
|
Age, Customized
Global cohort · <65 years
|
124 Participants
n=241 Participants • The results are presented by Global cohort and by China cohort.
|
122 Participants
n=238 Participants • The results are presented by Global cohort and by China cohort.
|
135 Participants
n=239 Participants • The results are presented by Global cohort and by China cohort.
|
381 Participants
n=718 Participants • The results are presented by Global cohort and by China cohort.
|
|
Age, Customized
Global cohort · >=65 years
|
117 Participants
n=241 Participants • The results are presented by Global cohort and by China cohort.
|
116 Participants
n=238 Participants • The results are presented by Global cohort and by China cohort.
|
104 Participants
n=239 Participants • The results are presented by Global cohort and by China cohort.
|
337 Participants
n=718 Participants • The results are presented by Global cohort and by China cohort.
|
|
Age, Customized
China cohort · <65 years
|
35 Participants
n=44 Participants • The results are presented by Global cohort and by China cohort.
|
30 Participants
n=43 Participants • The results are presented by Global cohort and by China cohort.
|
30 Participants
n=42 Participants • The results are presented by Global cohort and by China cohort.
|
95 Participants
n=129 Participants • The results are presented by Global cohort and by China cohort.
|
|
Age, Customized
China cohort · >=65 years
|
9 Participants
n=44 Participants • The results are presented by Global cohort and by China cohort.
|
13 Participants
n=43 Participants • The results are presented by Global cohort and by China cohort.
|
12 Participants
n=42 Participants • The results are presented by Global cohort and by China cohort.
|
34 Participants
n=129 Participants • The results are presented by Global cohort and by China cohort.
|
|
Sex/Gender, Customized
Global cohort · Female
|
241 Participants
n=241 Participants • The results are presented by Global cohort and by China cohort.
|
238 Participants
n=238 Participants • The results are presented by Global cohort and by China cohort.
|
239 Participants
n=239 Participants • The results are presented by Global cohort and by China cohort.
|
718 Participants
n=718 Participants • The results are presented by Global cohort and by China cohort.
|
|
Sex/Gender, Customized
China cohort · Female
|
44 Participants
n=44 Participants • The results are presented by Global cohort and by China cohort.
|
43 Participants
n=43 Participants • The results are presented by Global cohort and by China cohort.
|
42 Participants
n=42 Participants • The results are presented by Global cohort and by China cohort.
|
129 Participants
n=129 Participants • The results are presented by Global cohort and by China cohort.
|
|
Ethnicity (NIH/OMB)
Global cohort · Hispanic or Latino
|
20 Participants
n=241 Participants • The results are presented by Global cohort and by China cohort.
|
28 Participants
n=238 Participants • The results are presented by Global cohort and by China cohort.
|
32 Participants
n=239 Participants • The results are presented by Global cohort and by China cohort.
|
80 Participants
n=718 Participants • The results are presented by Global cohort and by China cohort.
|
|
Ethnicity (NIH/OMB)
Global cohort · Not Hispanic or Latino
|
218 Participants
n=241 Participants • The results are presented by Global cohort and by China cohort.
|
208 Participants
n=238 Participants • The results are presented by Global cohort and by China cohort.
|
206 Participants
n=239 Participants • The results are presented by Global cohort and by China cohort.
|
632 Participants
n=718 Participants • The results are presented by Global cohort and by China cohort.
|
|
Ethnicity (NIH/OMB)
Global cohort · Unknown or Not Reported
|
3 Participants
n=241 Participants • The results are presented by Global cohort and by China cohort.
|
2 Participants
n=238 Participants • The results are presented by Global cohort and by China cohort.
|
1 Participants
n=239 Participants • The results are presented by Global cohort and by China cohort.
|
6 Participants
n=718 Participants • The results are presented by Global cohort and by China cohort.
|
|
Ethnicity (NIH/OMB)
China cohort · Hispanic or Latino
|
0 Participants
n=44 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=43 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=42 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=129 Participants • The results are presented by Global cohort and by China cohort.
|
|
Ethnicity (NIH/OMB)
China cohort · Not Hispanic or Latino
|
44 Participants
n=44 Participants • The results are presented by Global cohort and by China cohort.
|
43 Participants
n=43 Participants • The results are presented by Global cohort and by China cohort.
|
42 Participants
n=42 Participants • The results are presented by Global cohort and by China cohort.
|
129 Participants
n=129 Participants • The results are presented by Global cohort and by China cohort.
|
|
Ethnicity (NIH/OMB)
China cohort · Unknown or Not Reported
|
0 Participants
n=44 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=43 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=42 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=129 Participants • The results are presented by Global cohort and by China cohort.
|
|
Race/Ethnicity, Customized
Global cohort · White
|
143 Participants
n=241 Participants • The results are presented by Global cohort and by China cohort.
|
136 Participants
n=238 Participants • The results are presented by Global cohort and by China cohort.
|
133 Participants
n=239 Participants • The results are presented by Global cohort and by China cohort.
|
412 Participants
n=718 Participants • The results are presented by Global cohort and by China cohort.
|
|
Race/Ethnicity, Customized
Global cohort · Asian
|
73 Participants
n=241 Participants • The results are presented by Global cohort and by China cohort.
|
72 Participants
n=238 Participants • The results are presented by Global cohort and by China cohort.
|
70 Participants
n=239 Participants • The results are presented by Global cohort and by China cohort.
|
215 Participants
n=718 Participants • The results are presented by Global cohort and by China cohort.
|
|
Race/Ethnicity, Customized
Global cohort · Black or African American
|
10 Participants
n=241 Participants • The results are presented by Global cohort and by China cohort.
|
11 Participants
n=238 Participants • The results are presented by Global cohort and by China cohort.
|
14 Participants
n=239 Participants • The results are presented by Global cohort and by China cohort.
|
35 Participants
n=718 Participants • The results are presented by Global cohort and by China cohort.
|
|
Race/Ethnicity, Customized
Global cohort · Other
|
10 Participants
n=241 Participants • The results are presented by Global cohort and by China cohort.
|
8 Participants
n=238 Participants • The results are presented by Global cohort and by China cohort.
|
12 Participants
n=239 Participants • The results are presented by Global cohort and by China cohort.
|
30 Participants
n=718 Participants • The results are presented by Global cohort and by China cohort.
|
|
Race/Ethnicity, Customized
Global cohort · American Indian or Alaska Native
|
0 Participants
n=241 Participants • The results are presented by Global cohort and by China cohort.
|
6 Participants
n=238 Participants • The results are presented by Global cohort and by China cohort.
|
6 Participants
n=239 Participants • The results are presented by Global cohort and by China cohort.
|
12 Participants
n=718 Participants • The results are presented by Global cohort and by China cohort.
|
|
Race/Ethnicity, Customized
Global cohort · Native Hawaiian or Other Pacific Islander
|
2 Participants
n=241 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=238 Participants • The results are presented by Global cohort and by China cohort.
|
1 Participants
n=239 Participants • The results are presented by Global cohort and by China cohort.
|
3 Participants
n=718 Participants • The results are presented by Global cohort and by China cohort.
|
|
Race/Ethnicity, Customized
Global cohort · Not reported
|
3 Participants
n=241 Participants • The results are presented by Global cohort and by China cohort.
|
5 Participants
n=238 Participants • The results are presented by Global cohort and by China cohort.
|
3 Participants
n=239 Participants • The results are presented by Global cohort and by China cohort.
|
11 Participants
n=718 Participants • The results are presented by Global cohort and by China cohort.
|
|
Race/Ethnicity, Customized
China cohort · White
|
0 Participants
n=44 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=43 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=42 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=129 Participants • The results are presented by Global cohort and by China cohort.
|
|
Race/Ethnicity, Customized
China cohort · Asian
|
44 Participants
n=44 Participants • The results are presented by Global cohort and by China cohort.
|
43 Participants
n=43 Participants • The results are presented by Global cohort and by China cohort.
|
42 Participants
n=42 Participants • The results are presented by Global cohort and by China cohort.
|
129 Participants
n=129 Participants • The results are presented by Global cohort and by China cohort.
|
|
Race/Ethnicity, Customized
China cohort · Black or African American
|
0 Participants
n=44 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=43 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=42 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=129 Participants • The results are presented by Global cohort and by China cohort.
|
|
Race/Ethnicity, Customized
China cohort · Other
|
0 Participants
n=44 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=43 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=42 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=129 Participants • The results are presented by Global cohort and by China cohort.
|
|
Race/Ethnicity, Customized
China cohort · American Indian or Alaska Native
|
0 Participants
n=44 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=43 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=42 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=129 Participants • The results are presented by Global cohort and by China cohort.
|
|
Race/Ethnicity, Customized
China cohort · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=43 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=42 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=129 Participants • The results are presented by Global cohort and by China cohort.
|
|
Race/Ethnicity, Customized
China cohort · Not reported
|
0 Participants
n=44 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=43 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=42 Participants • The results are presented by Global cohort and by China cohort.
|
0 Participants
n=129 Participants • The results are presented by Global cohort and by China cohort.
|
PRIMARY outcome
Timeframe: At baseline, every 9 weeks (wks) up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 monthsPopulation: Full Analysis Set (FAS) consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong.
To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 \[RECIST 1.1\]) in patients with newly diagnosed advanced or recurrent endometrial cancer
Outcome measures
| Measure |
Global Cohort - SoC
n=241 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab
n=238 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab + Olaparib
n=239 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC
n=44 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab
n=43 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab + Olaparib
n=42 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments
|
9.6 Months
Interval 9.0 to 9.9
|
10.2 Months
Interval 9.7 to 14.7
|
15.1 Months
Interval 12.6 to 20.7
|
9.7 Months
Interval 7.6 to 12.3
|
9.9 Months
Interval 8.2 to 20.6
|
9.9 Months
Interval 7.1 to 12.6
|
SECONDARY outcome
Timeframe: Survival assessed every 2 months after RECIST defined radiological progression; assessed through study completion, up to 83 monthsTo determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of OS
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, every 9 to 18 wks, then every 12 wks until objective radiological disease progression. Assessments then per local practice every 12 wks until second progression. Assessed until 12Apr2023 DCO (08Jul2024 DCO for China cohort), up to 50 monthsPopulation: FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong.
To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of PFS2
Outcome measures
| Measure |
Global Cohort - SoC
n=241 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab
n=238 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab + Olaparib
n=239 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC
n=44 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab
n=43 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab + Olaparib
n=42 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
|---|---|---|---|---|---|---|
|
Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice
|
19.1 Months
Interval 16.4 to 22.9
|
22.2 Months
Interval 18.7 to
Insufficient PFS2 events to estimate upper confidence limit.
|
NA Months
Insufficient PFS2 events to estimate median and confidence limits.
|
24.2 Months
Interval 15.5 to
Insufficient PFS2 events to estimate upper confidence limit.
|
19.7 Months
Interval 15.3 to
Insufficient PFS2 events to estimate upper confidence limit.
|
15.3 Months
Interval 12.7 to
Insufficient PFS2 events to estimate upper confidence limit.
|
SECONDARY outcome
Timeframe: At baseline, every 9 to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO (08 Jul 2024 DCO for China cohort), up to 50 monthsPopulation: All participants with measurable disease at baseline were included in the analysis. FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). China FAS includes all patients who were randomised at sites in China and Hong Kong. Odds ratio only calculated for Global cohort (per statistical analysis plan \[SAP\]).
To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of ORR
Outcome measures
| Measure |
Global Cohort - SoC
n=198 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab
n=202 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab + Olaparib
n=184 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC
n=37 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab
n=32 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab + Olaparib
n=33 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Based on Investigator Assessment
|
55.1 Percentage of participants
|
61.9 Percentage of participants
|
63.6 Percentage of participants
|
59.5 Percentage of participants
|
59.4 Percentage of participants
|
45.5 Percentage of participants
|
SECONDARY outcome
Timeframe: At baseline, every 9 wks up to 18 wks, then every 12 wks until objective radiological disease progression. Assessed until 12 Apr 2023 DCO, up to 35 monthsPopulation: All participants with confirmed response were included in the analysis. FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). This endpoint was not assessed in the China cohort as it was not prespecified in the statistical analysis plan (SAP).
To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of DoR
Outcome measures
| Measure |
Global Cohort - SoC
n=109 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab
n=125 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab + Olaparib
n=117 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab + Olaparib
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
|---|---|---|---|---|---|---|
|
Duration of Response (DoR) Based on Investigator Assessment
|
7.7 Months
Interval 5.1 to 13.5
|
13.1 Months
Interval 6.0 to
Insufficient DoR events to estimate upper confidence limit.
|
21.3 Months
Interval 8.1 to 29.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time elapsed from randomisation to first subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months)To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of TFST
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time elapsed from randomisation to second subsequent therapy or death. Assessed every 12 wks following treatment discontinuation, through study completion (up to 83 months)To determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of TSST
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time elapsed from randomisation to study treatment discontinuation or death. Assessed through study completion, up to 83 monthsTo determine the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of TDT
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK sampling performed on Day 85 pre-dose, Day 183 pre-dose, and 3 months after study treatment discontinuation (up to 36 months)Population: The Overall Number of Participants Analyzed reflects the total number of patients included in the PK Analysis Set, which comprises those treated with durvalumab per protocol and with valid PK data. However, PK concentrations were excluded at the sample level if they do not meet protocol-defined criteria. While some patients may not have any valid samples due to these exclusions, they remain part of the analysis population set by definition.
To characterise the pharmacokinetics (PK) of durvalumab and durvalumab in combination with olaparib
Outcome measures
| Measure |
Global Cohort - SoC
n=204 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab
n=213 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab + Olaparib
n=36 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC
n=35 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab + Olaparib
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
|---|---|---|---|---|---|---|
|
Serum Concentration of Durvalumab
Day 85, pre-dose (Trough concentration)
|
203.133538 μg/mL
Geometric Coefficient of Variation 32.6
|
196.218276 μg/mL
Geometric Coefficient of Variation 31.7
|
183.414442 μg/mL
Geometric Coefficient of Variation 32.7
|
NA μg/mL
Geometric Coefficient of Variation NA
As pre-specified in the Statistical Analysis Plan, three observations above the lower limit of quantification (LLOQ) are required as a minimum for a serum concentration to be summarised. Two observations above the LLOQ are presented as minimum and maximum with the other summary statistics as not calculated.
|
—
|
—
|
|
Serum Concentration of Durvalumab
Day 183, pre-dose (Trough concentration)
|
265.575840 μg/mL
Geometric Coefficient of Variation 39.6
|
236.315365 μg/mL
Geometric Coefficient of Variation 38.0
|
—
|
NA μg/mL
Geometric Coefficient of Variation NA
As pre-specified in the Statistical Analysis Plan, three observations above the lower limit of quantification (LLOQ) are required as a minimum for a serum concentration to be summarised. Two observations above the LLOQ are presented as minimum and maximum with the other summary statistics as not calculated.
|
—
|
—
|
|
Serum Concentration of Durvalumab
Follow-up 3-months (Last valid dose + 3 months)
|
27.977227 μg/mL
Geometric Coefficient of Variation 104.4
|
14.031316 μg/mL
Geometric Coefficient of Variation 206.8
|
33.310921 μg/mL
Geometric Coefficient of Variation 43.0
|
11.252155 μg/mL
Geometric Coefficient of Variation 1429.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Immunogenicity sampling performed on Day 1 pre-dose, Day 85 pre-dose, Day 183 pre-dose, and 3 and 6 months after study treatment discontinuation (up to 39 months)Population: ADA Analysis Set. This includes all patients who receive at least 1 dose of durvalumab and have non-missing baseline ADA and at least 1 post-baseline ADA result.
To characterise the immunogenicity of durvalumab and durvalumab in combination with olaparib
Outcome measures
| Measure |
Global Cohort - SoC
n=198 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab
n=207 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab + Olaparib
n=35 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC
n=33 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab + Olaparib
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
|---|---|---|---|---|---|---|
|
Anti-drug Antibodies (ADA) to Durvalumab
ADA positive post-baseline and positive at baseline
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Anti-drug Antibodies (ADA) to Durvalumab
Persistently positive
|
2 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Anti-drug Antibodies (ADA) to Durvalumab
Transiently positive
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Anti-drug Antibodies (ADA) to Durvalumab
Neutralising antibody positive at any visit
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Anti-drug Antibodies (ADA) to Durvalumab
ADA positive at baseline only
|
6 Number of participants
|
9 Number of participants
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Anti-drug Antibodies (ADA) to Durvalumab
ADA-positive at any visit (ADA prevalence)
|
8 Number of participants
|
9 Number of participants
|
0 Number of participants
|
1 Number of participants
|
—
|
—
|
|
Anti-drug Antibodies (ADA) to Durvalumab
Treatment-emergent ADA-positive (ADA incidence)
|
2 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Anti-drug Antibodies (ADA) to Durvalumab
Treatment-boosted ADA
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
|
Anti-drug Antibodies (ADA) to Durvalumab
Treatment-induced ADA (positive post-baseline only)
|
2 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.Population: FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). All participants with a baseline and post baseline physical functioning score available were analysed. This endpoint was not assessed in the China cohort as it was not prespecified in the SAP.
To determine effects on symptoms, functioning, and overall health related quality of life (HRQoL) of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy alone in newly diagnosed advanced or recurrent endometrial cancer patients. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function.
Outcome measures
| Measure |
Global Cohort - SoC
n=187 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab
n=190 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab + Olaparib
n=199 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab + Olaparib
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Physical Functioning Score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients 30 (EORTC QLQ-C30)
|
-5.3 Score on a scale
Standard Error 1.03
|
-3.6 Score on a scale
Standard Error 1.02
|
-5.9 Score on a scale
Standard Error 0.98
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.Population: FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). All participants with a baseline and post baseline global health status/QoL available were analysed. This endpoint was not assessed in the China cohort as it was not prespecified in the SAP.
To determine effects on symptoms, functioning, and overall HRQoL of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy alone in newly diagnosed advanced or recurrent endometrial cancer patients. The global health status/quality of life (QoL) is a score from 0 to 100. Higher scores on the global health status/QoL indicate better health status/function.
Outcome measures
| Measure |
Global Cohort - SoC
n=187 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab
n=190 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab + Olaparib
n=199 Participants
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab + Olaparib
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30
|
-2.8 Score on a scale
Standard Error 0.93
|
-2.7 Score on a scale
Standard Error 0.92
|
-3.6 Score on a scale
Standard Error 0.88
|
—
|
—
|
—
|
Adverse Events
Global Cohort - SoC
Global Cohort - SoC + Durvalumab
Global Cohort - SoC + Durvalumab + Olaparib
China Cohort - SoC
China Cohort - SoC + Durvalumab
China Cohort - SoC + Durvalumab + Olaparib
Serious adverse events
| Measure |
Global Cohort - SoC
n=236 participants at risk
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab
n=235 participants at risk
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab + Olaparib
n=238 participants at risk
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC
n=44 participants at risk
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab
n=41 participants at risk
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab + Olaparib
n=41 participants at risk
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Lung abscess
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Neutropenic sepsis
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Paracancerous pneumonia
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Pelvic infection
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Peritonitis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Pneumonia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.84%
2/238 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Pneumonia aspiration
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.84%
2/238 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Psoas abscess
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.85%
2/235 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Sepsis
|
1.3%
3/236 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.85%
2/235 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.7%
4/238 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Septic shock
|
0.85%
2/236 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Urinary tract infection
|
2.1%
5/236 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.85%
2/235 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.5%
6/238 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Urosepsis
|
1.3%
3/236 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
3/236 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/235 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.1%
5/238 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
West nile viral infection
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
3/236 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Occult blood
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Asthenia
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.84%
2/238 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.3%
3/236 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Death
|
0.85%
2/236 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Amylase increased
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.84%
2/238 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
International normalised ratio increased
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Liver function test abnormal
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Neutrophil count decreased
|
1.7%
4/236 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Platelet count decreased
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
White blood cell count decreased
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Dehydration
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.85%
2/236 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.84%
2/238 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.84%
2/238 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.7%
4/236 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.1%
5/235 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Starvation ketoacidosis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Eye disorders
Cataract
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Cardiac disorders
Left ventricular failure
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Cerebrovascular accident
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Dizziness
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Anaemia
|
4.2%
10/236 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.7%
16/238 • Number of events 33 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Meralgia paraesthetica
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Myxoedema coma
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Presyncope
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Secondary cerebellar degeneration
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Spinal cord compression
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Syncope
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Tremor
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Psychiatric disorders
Delirium
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Psychiatric disorders
Depression
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Renal and urinary disorders
Acute kidney injury
|
0.85%
2/236 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.84%
2/238 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Renal and urinary disorders
Hydronephrosis
|
0.85%
2/236 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Renal and urinary disorders
Renal failure
|
0.85%
2/236 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Renal and urinary disorders
Urinary retention
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.85%
2/235 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/238 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
4/236 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/238 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Endocrine disorders
Euthyroid sick syndrome
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.85%
2/235 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.85%
2/235 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Vascular disorders
Deep vein thrombosis
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.85%
2/235 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/238 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Vascular disorders
Embolism
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Vascular disorders
Embolism venous
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Vascular disorders
Hypertension
|
0.42%
1/236 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Vascular disorders
Hypotension
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Vascular disorders
Thrombosis
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Vascular disorders
Venous thrombosis limb
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Aplasia pure red cell
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/238 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Eye disorders
Retinal detachment
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Abdominal pain
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Colitis
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.85%
2/235 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Colonic fistula
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Constipation
|
1.3%
3/236 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.85%
2/235 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
4/236 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.84%
2/238 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.4%
8/236 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.7%
4/235 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.9%
7/238 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Dysphagia
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Faecal vomiting
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.85%
2/235 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Gastric perforation
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.85%
2/236 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.85%
2/235 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Nausea
|
0.85%
2/236 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/235 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Vomiting
|
0.85%
2/236 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.1%
5/235 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Fatigue
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
General physical health deterioration
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Hyperplasia
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Malaise
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Oedema peripheral
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Pain
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Pyrexia
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/238 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Hepatobiliary disorders
Immune-mediated cholangitis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Hepatobiliary disorders
Immune-mediated hepatic disorder
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Hepatobiliary disorders
Portal hypertension
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Immune system disorders
Contrast media allergy
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Abscess limb
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Appendicitis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Covid-19
|
1.3%
3/236 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.7%
4/238 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/238 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Cellulitis
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Hepatitis c
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
Other adverse events
| Measure |
Global Cohort - SoC
n=236 participants at risk
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab
n=235 participants at risk
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
Global Cohort - SoC + Durvalumab + Olaparib
n=238 participants at risk
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC
n=44 participants at risk
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.
Following completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab
n=41 participants at risk
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.
|
China Cohort - SoC + Durvalumab + Olaparib
n=41 participants at risk
Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.
Following completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.1%
5/238 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
8/236 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.7%
4/235 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.6%
11/238 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
15.9%
7/44 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Urinary tract infection
|
19.9%
47/236 • Number of events 65 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
13.6%
32/235 • Number of events 62 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
19.3%
46/238 • Number of events 67 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
18.2%
8/44 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.7%
30/236 • Number of events 48 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
14.5%
34/235 • Number of events 61 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
19.7%
47/238 • Number of events 85 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Injury, poisoning and procedural complications
Fall
|
4.2%
10/236 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.0%
14/235 • Number of events 14 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.3%
15/238 • Number of events 19 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
9.3%
22/236 • Number of events 28 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.0%
14/235 • Number of events 19 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.0%
12/238 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Alanine aminotransferase increased
|
7.6%
18/236 • Number of events 24 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.8%
30/235 • Number of events 37 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.6%
30/238 • Number of events 41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
38.6%
17/44 • Number of events 33 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
39.0%
16/41 • Number of events 28 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
26.8%
11/41 • Number of events 22 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Aspartate aminotransferase increased
|
7.2%
17/236 • Number of events 26 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.4%
22/235 • Number of events 26 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
8.4%
20/238 • Number of events 25 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
38.6%
17/44 • Number of events 35 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
31.7%
13/41 • Number of events 24 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
34.1%
14/41 • Number of events 26 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Bile acids increased
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.1%
4/44 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Blood alkaline phosphatase increased
|
2.5%
6/236 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.7%
11/235 • Number of events 13 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.4%
8/238 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.1%
4/44 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Blood bilirubin increased
|
1.7%
4/236 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.7%
4/235 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
11.4%
5/44 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Blood creatinine increased
|
5.5%
13/236 • Number of events 20 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.3%
10/235 • Number of events 13 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
10.1%
24/238 • Number of events 42 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
24.4%
10/41 • Number of events 21 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.9%
14/236 • Number of events 19 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.8%
9/235 • Number of events 15 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.4%
8/238 • Number of events 14 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.1%
4/44 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
17.1%
7/41 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Blood pressure increased
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.84%
2/238 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.7%
4/235 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/238 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.7%
4/236 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/235 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.7%
4/238 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.6%
18/236 • Number of events 30 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.8%
30/235 • Number of events 49 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
14.7%
35/238 • Number of events 70 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
11.4%
5/44 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Blood urea increased
|
1.7%
4/236 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/235 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/238 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.1%
4/44 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.1%
12/236 • Number of events 14 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.2%
17/235 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.3%
15/238 • Number of events 22 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
18.2%
8/44 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
22.0%
9/41 • Number of events 15 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
17.1%
7/41 • Number of events 15 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Hepatic enzyme increased
|
2.1%
5/236 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.7%
4/238 • Number of events 11 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.8%
3/44 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Lipase increased
|
4.7%
11/236 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.0%
7/235 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.1%
5/238 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.8%
3/44 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Lymphocyte count decreased
|
5.1%
12/236 • Number of events 21 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.7%
11/235 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.0%
12/238 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
13.6%
6/44 • Number of events 28 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
17.1%
7/41 • Number of events 24 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
24.4%
10/41 • Number of events 32 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Neutrophil count decreased
|
25.4%
60/236 • Number of events 159 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
18.3%
43/235 • Number of events 105 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
21.0%
50/238 • Number of events 145 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
68.2%
30/44 • Number of events 138 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
73.2%
30/41 • Number of events 132 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
70.7%
29/41 • Number of events 149 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Neutrophil count increased
|
0.42%
1/236 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.85%
2/235 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Platelet count decreased
|
15.7%
37/236 • Number of events 73 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
15.3%
36/235 • Number of events 61 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
16.4%
39/238 • Number of events 71 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
47.7%
21/44 • Number of events 66 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
31.7%
13/41 • Number of events 24 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
36.6%
15/41 • Number of events 38 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Weight decreased
|
9.7%
23/236 • Number of events 28 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
8.5%
20/235 • Number of events 24 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.1%
17/238 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
13.6%
6/44 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
19.5%
8/41 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
Weight increased
|
3.0%
7/236 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.0%
7/235 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.2%
10/238 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
11.4%
5/44 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
White blood cell count decreased
|
16.9%
40/236 • Number of events 111 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.3%
29/235 • Number of events 67 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
16.0%
38/238 • Number of events 112 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
72.7%
32/44 • Number of events 159 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
73.2%
30/41 • Number of events 129 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
75.6%
31/41 • Number of events 161 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Investigations
White blood cells urine positive
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 19 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.5%
46/236 • Number of events 60 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
17.9%
42/235 • Number of events 57 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
23.1%
55/238 • Number of events 83 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.8%
3/44 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
24.4%
10/41 • Number of events 18 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.43%
1/235 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.1%
4/44 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.6%
18/236 • Number of events 25 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.4%
8/235 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.1%
17/238 • Number of events 19 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
11.4%
5/44 • Number of events 11 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
17.1%
7/41 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.4%
8/236 • Number of events 11 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.1%
5/235 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.9%
7/238 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.42%
1/236 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/235 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/238 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
15.9%
7/44 • Number of events 13 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.3%
3/236 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/235 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
20.5%
9/44 • Number of events 18 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
19.5%
8/41 • Number of events 26 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.7%
4/236 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.8%
9/235 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.2%
10/238 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.1%
4/44 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
22.0%
9/41 • Number of events 19 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
17.1%
7/41 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.1%
5/236 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.1%
5/235 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.84%
2/238 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.8%
3/44 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.5%
20/236 • Number of events 37 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
11.1%
26/235 • Number of events 42 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
11.3%
27/238 • Number of events 49 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
25.0%
11/44 • Number of events 29 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
17.1%
7/41 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
19.5%
8/41 • Number of events 15 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.1%
38/236 • Number of events 53 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
16.2%
38/235 • Number of events 49 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
16.0%
38/238 • Number of events 66 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
20.5%
9/44 • Number of events 18 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.8%
9/236 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.4%
8/235 • Number of events 11 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.0%
12/238 • Number of events 22 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.1%
4/44 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
22.0%
9/41 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.3%
3/236 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/235 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/238 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.6%
58/236 • Number of events 89 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
29.8%
70/235 • Number of events 112 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
24.4%
58/238 • Number of events 98 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
11.4%
5/44 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
14.6%
6/41 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.3%
22/236 • Number of events 33 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
8.1%
19/235 • Number of events 23 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
14.7%
35/238 • Number of events 39 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.8%
3/44 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.3%
22/236 • Number of events 25 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.8%
16/235 • Number of events 19 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.6%
11/238 • Number of events 16 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.1%
12/236 • Number of events 16 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.0%
7/235 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.4%
8/238 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.4%
15/236 • Number of events 19 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.4%
15/235 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.5%
13/238 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.6%
44/236 • Number of events 73 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
13.6%
32/235 • Number of events 47 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.6%
30/238 • Number of events 33 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.8%
35/236 • Number of events 42 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
13.2%
31/235 • Number of events 44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
29/238 • Number of events 38 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
22.7%
10/44 • Number of events 15 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
14.6%
6/41 • Number of events 13 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
22.0%
9/41 • Number of events 11 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Dizziness
|
12.7%
30/236 • Number of events 38 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
13.6%
32/235 • Number of events 37 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
16.8%
40/238 • Number of events 50 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.8%
3/44 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Dysgeusia
|
11.0%
26/236 • Number of events 27 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
10.2%
24/235 • Number of events 28 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
11.3%
27/238 • Number of events 33 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Headache
|
14.8%
35/236 • Number of events 42 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.8%
30/235 • Number of events 34 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
16.4%
39/238 • Number of events 49 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Hypoaesthesia
|
5.1%
12/236 • Number of events 19 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.8%
9/235 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.3%
15/238 • Number of events 19 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
36.4%
16/44 • Number of events 24 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
17.1%
7/41 • Number of events 11 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
43.9%
18/41 • Number of events 21 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Anaemia
|
51.3%
121/236 • Number of events 160 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
47.2%
111/235 • Number of events 168 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
59.2%
141/238 • Number of events 242 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
81.8%
36/44 • Number of events 101 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
68.3%
28/41 • Number of events 70 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
82.9%
34/41 • Number of events 88 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Neuropathy peripheral
|
28.0%
66/236 • Number of events 83 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
26.0%
61/235 • Number of events 69 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
25.2%
60/238 • Number of events 74 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Paraesthesia
|
4.2%
10/236 • Number of events 11 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.5%
13/235 • Number of events 14 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.5%
6/238 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
28.0%
66/236 • Number of events 74 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
25.5%
60/235 • Number of events 69 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
25.2%
60/238 • Number of events 66 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Psychiatric disorders
Insomnia
|
14.0%
33/236 • Number of events 35 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
10.2%
24/235 • Number of events 28 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
29/238 • Number of events 31 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
13.6%
6/44 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
17.1%
7/41 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/236 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Renal and urinary disorders
Dysuria
|
5.1%
12/236 • Number of events 16 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.3%
10/235 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.2%
10/238 • Number of events 11 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Renal and urinary disorders
Haematuria
|
4.7%
11/236 • Number of events 11 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.7%
4/235 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.9%
7/238 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Renal and urinary disorders
Pollakiuria
|
6.4%
15/236 • Number of events 15 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.3%
3/235 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.8%
9/238 • Number of events 11 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/235 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/238 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.8%
3/44 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.7%
4/236 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.7%
4/235 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.5%
13/238 • Number of events 13 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.5%
13/236 • Number of events 15 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.7%
11/235 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.8%
9/238 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.6%
25/236 • Number of events 31 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
14.9%
35/235 • Number of events 38 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
13.4%
32/238 • Number of events 40 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
22.0%
9/41 • Number of events 11 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
14.6%
6/41 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.6%
25/236 • Number of events 29 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
11.5%
27/235 • Number of events 34 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
29/238 • Number of events 36 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
118/236 • Number of events 118 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
50.2%
118/235 • Number of events 122 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
50.8%
121/238 • Number of events 124 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
65.9%
29/44 • Number of events 29 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
48.8%
20/41 • Number of events 20 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
63.4%
26/41 • Number of events 26 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.3%
29/236 • Number of events 41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
15.3%
36/235 • Number of events 42 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
15.5%
37/238 • Number of events 58 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
13.6%
6/44 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.4%
27/236 • Number of events 32 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
17.4%
41/235 • Number of events 59 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
11.8%
28/238 • Number of events 38 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
13.6%
6/44 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
26.8%
11/41 • Number of events 33 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
17.1%
7/41 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.5%
6/236 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.5%
13/235 • Number of events 16 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.3%
15/238 • Number of events 23 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Vascular disorders
Hypertension
|
5.5%
13/236 • Number of events 18 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.3%
10/235 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.5%
13/238 • Number of events 27 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.1%
4/44 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Endocrine disorders
Hyperthyroidism
|
1.7%
4/236 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.4%
15/235 • Number of events 16 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.5%
13/238 • Number of events 15 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
14.6%
6/41 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Endocrine disorders
Hypothyroidism
|
3.4%
8/236 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
15.7%
37/235 • Number of events 44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
13.9%
33/238 • Number of events 42 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.1%
4/44 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
24.4%
10/41 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Eye disorders
Vision blurred
|
4.2%
10/236 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.1%
12/235 • Number of events 15 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.8%
9/238 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Abdominal distension
|
4.7%
11/236 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.3%
10/235 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.5%
13/238 • Number of events 15 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.8%
3/44 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Abdominal pain
|
16.1%
38/236 • Number of events 39 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
16.2%
38/235 • Number of events 49 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
16.8%
40/238 • Number of events 53 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.8%
3/44 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 14 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.5%
13/236 • Number of events 13 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.4%
8/235 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.5%
6/238 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
10/236 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.8%
16/235 • Number of events 17 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.9%
14/238 • Number of events 16 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.1%
4/44 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Constipation
|
33.9%
80/236 • Number of events 102 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
26.8%
63/235 • Number of events 80 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
32.8%
78/238 • Number of events 105 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
22.7%
10/44 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
26.8%
11/41 • Number of events 18 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Diarrhoea
|
27.1%
64/236 • Number of events 101 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
31.5%
74/235 • Number of events 115 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
28.2%
67/238 • Number of events 114 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
22.7%
10/44 • Number of events 13 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
14.6%
6/41 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Dry mouth
|
2.1%
5/236 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.1%
5/235 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.8%
9/238 • Number of events 14 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Dyspepsia
|
7.6%
18/236 • Number of events 21 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.1%
12/235 • Number of events 13 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.2%
22/238 • Number of events 28 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Nausea
|
44.5%
105/236 • Number of events 182 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
40.4%
95/235 • Number of events 157 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
54.2%
129/238 • Number of events 237 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
40.9%
18/44 • Number of events 30 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
26.8%
11/41 • Number of events 30 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
43.9%
18/41 • Number of events 60 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Stomatitis
|
7.6%
18/236 • Number of events 24 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
8.1%
19/235 • Number of events 20 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
10.5%
25/238 • Number of events 31 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Toothache
|
0.42%
1/236 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.0%
7/235 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.7%
4/238 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Gastrointestinal disorders
Vomiting
|
17.8%
42/236 • Number of events 72 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
19.6%
46/235 • Number of events 73 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
25.6%
61/238 • Number of events 93 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
25.0%
11/44 • Number of events 15 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
26.8%
11/41 • Number of events 25 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
43.9%
18/41 • Number of events 37 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Asthenia
|
9.7%
23/236 • Number of events 34 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.4%
22/235 • Number of events 31 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
18.5%
44/238 • Number of events 72 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/44 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Chest discomfort
|
1.7%
4/236 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.7%
4/235 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.1%
5/238 • Number of events 7 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Fatigue
|
36.9%
87/236 • Number of events 127 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
34.9%
82/235 • Number of events 101 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
39.1%
93/238 • Number of events 143 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.1%
4/44 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
14.6%
6/41 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Influenza like illness
|
3.4%
8/236 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.3%
10/235 • Number of events 14 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.8%
9/238 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
14.6%
6/41 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.9%
2/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Malaise
|
6.8%
16/236 • Number of events 21 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.0%
14/235 • Number of events 31 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.0%
12/238 • Number of events 18 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.8%
3/44 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 5 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
22.0%
9/41 • Number of events 13 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Oedema peripheral
|
8.9%
21/236 • Number of events 23 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.3%
29/235 • Number of events 35 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.6%
30/238 • Number of events 37 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.00%
0/41 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Pain
|
3.8%
9/236 • Number of events 14 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.6%
6/235 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.2%
10/238 • Number of events 14 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.8%
3/44 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
12.2%
5/41 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Peripheral swelling
|
2.5%
6/236 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
3.4%
8/235 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.2%
10/238 • Number of events 12 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.3%
1/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
2.4%
1/41 • Number of events 1 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
General disorders
Pyrexia
|
7.6%
18/236 • Number of events 20 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
8.5%
20/235 • Number of events 27 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.7%
23/238 • Number of events 30 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
17.1%
7/41 • Number of events 10 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.3%
3/236 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
1.7%
4/235 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
0.42%
1/238 • Number of events 2 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
4.5%
2/44 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 3 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
7.3%
3/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.8%
9/236 • Number of events 14 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
5.1%
12/235 • Number of events 25 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.3%
15/238 • Number of events 37 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
6.8%
3/44 • Number of events 6 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
14.6%
6/41 • Number of events 25 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
17.1%
7/41 • Number of events 22 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
|
Infections and infestations
Covid-19
|
12.3%
29/236 • Number of events 29 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
14.9%
35/235 • Number of events 36 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
18.5%
44/238 • Number of events 46 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
13.6%
6/44 • Number of events 8 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
19.5%
8/41 • Number of events 9 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
9.8%
4/41 • Number of events 4 • Adverse events (AEs) with onset date or that worsen on or after first dose of study treatment) up until the initiation of the first subsequent anticancer therapy following discontinuation of study treatment or until the end of safety follow-up period (latest of 30 days following discontinuation of olaparib/placebo or 90 days following discontinuation of durvalumab/placebo), whichever occurs first. DCO: 12 Apr 2023 (08 Jul 2024 for China cohort), up to 50 months
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment. MedDRA 25.1 and 27.0 were used to code AEs in the Global and China cohorts, respectively. If the PT is not part of the MedDRA dictionary, the count is presented as zero. Otherwise, zero means that the term is part of the MedDRA version but no events were observed. Included in MedDRA 25.1 but not in MedDRA 27.0: Myxoedema coma Included in MedDRA 27.0 but not in MedDRA 25.1: Bile acids increased
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years after completion of the Study shall require the Sponsor's prior written consent.
- Publication restrictions are in place
Restriction type: OTHER