Durvalumab Treatment in Combination With Chemotherapy and... | NCT03737643 | Trialant
NCT03737643
Sponsor
AstraZeneca
Status
Active, not recruiting
Last Update Posted
Jul 7, 2026Actual
Enrollment
1,407Actual
Phase
Phase 3
Conditions
Advanced Ovarian Cancer
Interventions
Bevacizumab
Durvalumab
Olaparib
Placebo olaparib
Durvalumab placebo
Carboplatin+Paclitaxel
Countries
United States
Austria
Belgium
Brazil
Bulgaria
Canada
China
Denmark
Finland
France
Germany
Hungary
Italy
Japan
Peru
Poland
Romania
South Korea
Spain
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT03737643
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D081RC00001
Secondary IDs
ID
Type
Description
Link
2017-004632-11
EudraCT Number
Brief Title
Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients
Official Title
A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).
Acronym
DUO-O
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Jul 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 4, 2019Actual
Primary Completion Date
Mar 17, 2025Actual
Completion Date
Dec 23, 2026Estimated
First Submitted Date
Oct 15, 2018
First Submission Date that Met QC Criteria
Nov 8, 2018
First Posted Date
Nov 9, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Mar 13, 2026
Results First Submitted that Met QC Criteria
Jun 8, 2026
Results First Posted Date
Jun 9, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 3, 2026
Last Update Posted Date
Jul 7, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Name
Class
European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
GOG Foundation
NETWORK
Myriad Genetic Laboratories, Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.
Detailed Description
Eligible patients will be those patients with newly diagnosed, histologically confirmed advanced (Fédération Internationale de Gynécologie et d'Obstétrique [FIGO] Stage III-IV) ovarian, primary peritoneal cancer and/or fallopian-tube cancer. All patients should be candidates for cytoreductive surgery which could be conducted as immediate upfront primary surgery following diagnosis or can be conducted after initiation of platinum based neoadjuvant chemotherapy. All patients should be eligible to start first line platinum based chemotherapy in combination with bevacizumab.
The study aims to evaluate the efficacy and safety of standard of care (SoC) platinum-based chemotherapy and bevacizumab followed by maintenance bevacizumab either as monotherapy, or in combination with durvalumab, or in combination with durvalumab and olaparib. Therefore, this study aims to see which combination allows patients to live longer without the cancer coming back or getting worse. The study is also looking to see which combination makes patients live longer and how the treatment and the cancer affects their quality of life.
Conditions Module
Conditions
Advanced Ovarian Cancer
Keywords
Advanced Ovarian Cancer
Ovarian neoplasms
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,407Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1
Active Comparator
Platinum-based chemotherapy in combination with bevacizumab and durvalumab placebo (saline IV infusion) followed by maintenance bevacizumab, durvalumab placebo (saline IV infusion) and olaparib placebo (tablets).
Drug: Bevacizumab
Drug: Placebo olaparib
Drug: Durvalumab placebo
Drug: Carboplatin+Paclitaxel
Arm 2
Experimental
Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib placebo.
Drug: Bevacizumab
Drug: Durvalumab
Drug: Placebo olaparib
Drug: Carboplatin+Paclitaxel
Arm 3
Experimental
Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib.
Drug: Bevacizumab
Drug: Durvalumab
Drug: Olaparib
Drug: Carboplatin+Paclitaxel
tBRCAm cohort
Experimental
Platinum-based chemotherapy in combination with bevacizumab and durvalumab followed by maintenance bevacizumab, durvalumab and olaparib. Bevacizumab is optional according to local practice.
Drug: Bevacizumab
Drug: Durvalumab
Drug: Olaparib
Drug: Carboplatin+Paclitaxel
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Bevacizumab
Drug
Bevacizumab by intravenous infusion. In tBRCAm cohort bevacizumab is optional according to local practice.
Arm 1
Arm 2
Arm 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
To determine the efficacy of durvalumab in combination with platinum based chemotherapy and bevacizumab and continued as maintenance in combination with bevacizumab and olaparib versus SoC platinum based chemotherapy in combination with bevacizumab by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 [RECIST 1.1]) in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Per MTP, the comparison of SoC+D+O v SoC in the Non-tbRCAm patients is a primary endpoint. SoC+D v SoC is reported separately as a secondary endpoint. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until primary analysis - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - (Full Analysis Set, HRD Positive)
To determine the efficacy of durvalumab and olaparib assessed by PFS in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Per MTP, the comparison of SoC+D+O v SoC in the Non-tBRCAm HRD positve population is a primary endpoint. SoC+D v SoC is reported separately as a secondary endpoint. Results for tBRCAm SoC+D+O are not presented as as this was prespecified to be assessed only in the Non-tBRCAm patients.
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until DCO1 - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months
Secondary Outcomes
Measure
Description
Time Frame
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
To determine the efficacy of durvalumab assessed by PFS in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Per MTP, the comparison of SoC+D v SoC is a secondary endpoint. SoC+D+O v SoC is reported separately as a primary endpoint. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Female patients with newly diagnosed, histologically confirmed, advanced (Stage III-IV) high grade epithelial ovarian cancer including high grade serious, high grade endometriod, clear cell ovarian cancer or carcinosarcoma, primary peritoneal cancer and / or fallopian-tube cancer
Patients must be aged ≥18 years of age. For patients enrolled in Japan that are aged <20 year
All patients should be candidates for cytoreductive surgery either: upfront primary surgery OR plan to undergo chemotherapy with interval debulking surgery
Evidence of presence or absence of BRCA1/2 mutation in tumour tissue
Mandatory provision of tumour sample for centralised tBRCA testing
ECOG performance status 0-1
Patients must have preserved organ and bone marrow function
Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test
Prior systemic anti-cancer therapy for ovarian cancer
Inability to determine the presence or absence of a deleterious or suspected deleterious BRCA mutation
Prior treatment with PARP inhibitor or immune mediated therapy
Planned intraperitoneal cytotoxic chemotherapy
Active or prior documented autoimmune or inflammatory disorders
Patients considered a poor medical risk due to a serious, uncontrolled intercurrent illness
Clinically significant cardiovascular disease
Patients with known brain metastases
History of another primary malignancy except for:
Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study treatment and of low potential risk for recurrence (patients who have received prior adjuvant chemotherapy for early stage breast cancer may be eligible, provided that it was completed ≥3 years prior to registration, and that the patient remains free of recurrent or metastatic disease)
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated carcinoma in situ without evidence of disease
Endometrial cancer FIGO Stage IA, Grade 1 or Grade 2
Persistent toxicities CTCAE Grade >2 caused by previous cancer therapy
Patients with a known hypersensitivity to olaparib, durvalumab or any of the excipients of these products and to the combination/comparator agents
Breast feeding women
Accepts Healthy Volunteers
No
Sex
Female
Sex/Gender Based
Yes
Sex/Gender Description
All female patients newly diagnosed with advanced ovarian cancer
Minimum Age
18 Years
Maximum Age
130 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Philipp Harter
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
This study planned to allocate/randomise approximately 1254 patients with newly-diagnosed advanced ovarian cancer patients. In addition, a China cohort of approximately 120 non-tBRCAm patients with newly-diagnosed advanced ovarian cancer patients was planned to be randomised.
Recruitment Details
Overall, 1407 patients were randomised into the study.
Global Cohort: 1502 patients screened across 179 sites in 20 countries. 1130 were randomised in the Non-tBRCAm cohort and 154 allocated to the tBRCAm cohort.
China Cohort: 134 patients screened across 29 sites; 124 were randomized. 1 patient in the China cohort was randomised prior to Global recruitment closure and hence included in both the Global and China cohort summaries. No patients in the tBRCAm cohort were enrolled from China
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 24, 2024
Mar 16, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The study consists of 2 independent cohorts: 3 double-blind treatment arms cohort for patients with no tBRCA mutation, and a single open label arm cohort for patients with tBRCA mutation
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. For global cohort, assessed until DCO2 (18SEP2023) - up to 55 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.
Overall Survival - Full Analysis Set
To determine the efficacy of durvalumab and olaparib assessed by OS in the first line treatment patients with newly diagnosed advanced ovarian cancer.
Overall survival (OS) is defined as the time from randomisation/allocation to death due to any cause regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy.
Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Survival assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
To determine the efficacy of durvalumab and olaparib assessed by OS in the first line treatment patients with newly diagnosed advanced ovarian cancer.
Overall survival (OS) is defined as the time from randomisation/allocation to death due to any cause regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy.
Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Survival assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
Time to Second Progression or Death Based on Local Standard Clinical Practice (PFS2) - Full Analysis Set
To assess the efficacy of durvalumab and olaparib in terms of PFS2 in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to second progression or death (PFS2) is defined as the time from the date of randomisation/allocation to the earliest of the progression event subsequent to first subsequent therapy or death.
Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.
Time to Second Progression or Death Based on Local Standard Clinical Practice (PFS2) - (Full Analysis Set, HRD-positive)
To assess the efficacy of durvalumab and olaparib in terms of PFS2 in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to second progression or death (PFS2) is defined as the time from the date of randomisation/allocation to the earliest of the progression event subsequent to first subsequent therapy or death.
Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
Assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.
Objective Response Rate Based on Investigator Assessment (Full Analysis Set)
To assess the efficacy of durvalumab and olaparib in terms of ORR (Complete Response + Partial Response) by investigator assessment by modified RECIST 1.1:
in all patients with evaluable disease at baseline
prior to surgery in those patients planned to have IDS with evaluable disease at baseline.
Objective response rate (ORR) is defined similarly for the non-tBRCAm and tBRCAm cohorts as the number (percentage) of patients with at least one investigator-assessed visit response of CR or PR and will be based on a subset of all randomised/allocated patients who have evaluable disease at baseline per the site investigator.
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for Global tBRCAm (DCO1 05DEC2022) and China (DCO1 17MAR2025)
Objective Response Rate Based on Investigator Assessment (Full Analysis Set, HRD-positive)
To assess the efficacy of durvalumab and olaparib in terms of ORR (Complete Response + Partial Response) by investigator assessment by modified RECIST 1.1
in all patients with evaluable disease at baseline
prior to surgery in those patients planned to have IDS with evaluable disease at baseline.
Objective response rate (ORR) is defined similarly for the non-tBRCAm and tBRCAm cohorts as the number (percentage) of patients with at least one investigator-assessed visit response of CR or PR and will be based on a subset of all randomised/allocated patients who have evaluable disease at baseline per the site investigator.
This was prespecified to be assessed only in the non-tBRCAm cohort.
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for China (DCO1 17MAR2025)
Duration of Objective Response Based on Investigator Assessments (Full Analysis Set)
To assess the efficacy of durvalumab and olaparib in terms of duration of response (DoR) in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Duration of response (DoR) is defined similarly for the non-tBRCAm and tBRCAm cohorts using the corresponding FAS among patients with a response (CR or PR), as the time from the date of first documented response (i.e., the first time at which the visit response is PR or CR) according to modified RECIST v1.1 as assessed by the investigator until date of documented progression or death in the absence of disease progression.
This was prespecified to be assessed only in the Global patients.
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for Global tBRCAm (DCO1 05DEC2022)
Duration of Objective Response Based on Investigator Assessments (Full Analysis Set, HRD-positive)
To assess the efficacy of durvalumab and olaparib in terms of duration of response (DoR) in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Duration of response (DoR) is defined similarly for the non-tBRCAm and tBRCAm cohorts using the corresponding FAS among patients with a response (CR or PR), as the time from the date of first documented response (i.e., the first time at which the visit response is PR or CR) according to modified RECIST v1.1 as assessed by the investigator until date of documented progression or death in the absence of disease progression.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023).
Time to First Subsequent Therapy (TFST) - Full Analysis Set
To assess the efficacy of durvalumab and olaparib in terms of TFST in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to start of first subsequent therapy or death (TFST) is defined as the time from randomisation/allocation to the earlier of first subsequent therapy start date following study treatment discontinuation, or death.
This was prespecified to be assessed only in Non-tBRCAm patients.
Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
Time to First Subsequent Therapy (TFST) - (Full Analysis Set, HRD-positive)
To assess the efficacy of durvalumab and olaparib in terms of TFST in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to start of first subsequent therapy or death (TFST) is defined as the time from randomisation/allocation to the earlier of first subsequent therapy start date following study treatment discontinuation, or death.
This was prespecified to be assessed only in Non-tBRCAm patients.
Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
Time to Second Subsequent Therapy (TSST) - Full Analysis Set
To assess the efficacy of durvalumab and olaparib in terms of TSST in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to second subsequent therapy or death (TSST) is defined as the time from randomisation/allocation to the earlier of the second subsequent anti-cancer therapy start date following study treatment discontinuation, or death.
This was prespecified to be assessed only in Non-tBRCAm patients.
Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
Time to Second Subsequent Therapy (TSST) - (Full Analysis Set, HRD-positive)
To assess the efficacy of durvalumab and olaparib in terms of TSST in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to second subsequent therapy or death (TSST) is defined as the time from randomisation to the earlier of the second subsequent anti-cancer therapy start date following study treatment discontinuation, or death.
This was prespecified to be assessed only in Non-tBRCAm patients.
Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
Time to Treatment Discontinuation (TDT) - Full Analysis Set
To assess the efficacy of durvalumab and olaparib in terms of TDT in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to permanent study treatment discontinuation or death (TDT) is defined as the time from randomisation/allocation to the earlier of the date of permanent study treatment discontinuation or death.
This was prespecified to be assessed only in Non-tBRCAm patients.
Assessed through study completion, up to 73 months for global non-tBRCAm (DCO3 17MAR2025) and up to 46 months for and China (DCO1 17MAR2025)
Time to Treatment Discontinuation (TDT) - (Full Analysis Set, HRD-positive)
To assess the efficacy of durvalumab and olaparib in terms of TDT in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to permanent study treatment discontinuation or death (TDT) is defined as the time from randomisation/allocation to the earlier of the date of permanent study treatment discontinuation or death.
This was prespecified to be assessed only in Non-tBRCAm patients.
Assessed through study completion, up to 73 months for global non-tBRCAm (DCO3 17MAR2025) and up to 46 months for and China (DCO1 17MAR2025)
Change From Baseline in Physical Function Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - Full Analysis Set
To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
Assessed at week 96.
Change From Baseline in Physical Function Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - (Full Analysis Set, HRD Positive)
To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
Assessed at week 96.
Change From Baseline in Global Health Status/QoL Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - Full Analysis Set
To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. 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.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
Assessed at week 96.
Change From Baseline in Global Health Status/QoL Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - (Full Analysis Set, HRD Positive)
To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. 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.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
Assessed at week 96
Summary of Serum Concentrations (μg/mL) of Durvalumab for Each Treatment - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (Pharmacokinetic Analysis Set)
To characterize the PK of durvalumab in combination with bevacizumab and olaparib.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
Assessed at Day 85 pre-dose, Day 183 pre-dose and 3 months after last dose of durvalumab.
Summary of Plasma Concentrations (μg/mL) of Olaparib - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (Pharmacokinetic Analysis Set)
To determine olaparib plasma concentrations via sparse sampling for population PK analyses.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
Assessed on Day 148 post-dose (1-3 hours, 3-6 hours and 6-12 hours)
Summary of ADA Responses During the Study for Durvalumab - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (ADA Analysis Set)
To characterize the immunogenicity of durvalumab in combination with bevacizumab and olaparib.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
Assessed pre-infusion at Cycle 2, Cycle 4, Cycle 6 and the third cycle of the maintenance phase as well as 3 months after last dose of durvalumab
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
FG002
Global Non-tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
FG003
Global tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
FG004
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
FG005
China Non-tBRCAm: SoC + Durvalumab
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
FG006
China Non-tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
FG000378 subjects
FG001374 subjects
FG002378 subjects
FG003154 subjects
FG00440 subjects
FG00543 subjects
FG00641 subjects
COMPLETED
Patients ongoing study at final OS analysis (DCO3) for Global cohort and primary PFS analysis (DCO1) for China cohort - 17MARCH2025
FG000153 subjects
FG001160 subjects
FG002172 subjects
FG003100 subjects
FG00426 subjects
FG00531 subjects
FG00634 subjects
NOT COMPLETED
FG000225 subjects
FG001214 subjects
FG002206 subjects
FG00354 subjects
FG00414 subjects
FG00512 subjects
FG0067 subjects
Type
Comment
Reasons
Death
FG000201 subjects
FG001196 subjects
FG002186 subjects
FG00346 subjects
FG00414 subjects
FG00511 subjects
FG0067 subjects
Withdrawal by Subject
FG00022 subjects
FG00117 subjects
FG00220 subjects
FG0037 subjects
FG004
Pre-mature site closure and screen failure,
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
1 patient in the China cohort is also included in the Global cohort. Patient is randomised to SoC+Durvalumab.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
BG001
Global Non-tBRCAm: SoC + Durvalumab
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
BG002
Global Non-tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
BG003
Global tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
BG004
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
BG005
China Non-tBRCAm: SoC + Durvalumab
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
BG006
China Non-tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000378
BG001374
BG002378
BG003154
BG00440
BG00543
BG00641
BG0071408
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00058.7± 9.9
BG00158.5± 10.8
BG00260.2± 10.4
BG003
Age, Customized
Number
Participants
Title
Denominators
Categories
>=65
Title
Measurements
BG000110
BG001126
BG002
Sex/Gender, Customized
Number
Participants
Title
Denominators
Categories
Female
Title
Measurements
BG000378
BG001374
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00029
BG00120
BG002
Race/Ethnicity, Customized
Number
Participants
Title
Denominators
Categories
AMERICAN INDIAN OR ALASKA NATIVE
Title
Measurements
BG0004
BG0014
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Secondary
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
To determine the efficacy of durvalumab assessed by PFS in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Per MTP, the comparison of SoC+D v SoC is a secondary endpoint. SoC+D+O v SoC is reported separately as a primary endpoint. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
95% Confidence Interval
Months
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. For global cohort, assessed until DCO2 (18SEP2023) - up to 55 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG002
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG003
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
Units
Counts
Participants
OG000378
OG001374
OG00240
OG003
Title
Denominators
Categories
Title
Measurements
OG00019.3(17.9 to 20.4)
OG00120.6(18.7 to 22.5)
OG00217.4(11.7 to 26.4)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
The p-value is calculated using a log rank test stratified by timing and outcome of cytoreductive surgery' and 'geographic region'.
0.1133
Hazard Ratio (HR)
0.87
2-Sided
95
0.74
1.03
A HR less than 1 favours SoC+D
Superiority
OG002
OG003
Secondary
Overall Survival - Full Analysis Set
To determine the efficacy of durvalumab and olaparib assessed by OS in the first line treatment patients with newly diagnosed advanced ovarian cancer.
Overall survival (OS) is defined as the time from randomisation/allocation to death due to any cause regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy.
Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
95% Confidence Interval
Months
Survival assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
To determine the efficacy of durvalumab and olaparib assessed by OS in the first line treatment patients with newly diagnosed advanced ovarian cancer.
Overall survival (OS) is defined as the time from randomisation/allocation to death due to any cause regardless of whether the patient withdraws from randomised therapy or receives another anti-cancer therapy.
Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
95% Confidence Interval
Months
Survival assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
Secondary
Time to Second Progression or Death Based on Local Standard Clinical Practice (PFS2) - Full Analysis Set
To assess the efficacy of durvalumab and olaparib in terms of PFS2 in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to second progression or death (PFS2) is defined as the time from the date of randomisation/allocation to the earliest of the progression event subsequent to first subsequent therapy or death.
Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
95% Confidence Interval
Months
Assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Primary
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - Full Analysis Set
To determine the efficacy of durvalumab in combination with platinum based chemotherapy and bevacizumab and continued as maintenance in combination with bevacizumab and olaparib versus SoC platinum based chemotherapy in combination with bevacizumab by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 [RECIST 1.1]) in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Per MTP, the comparison of SoC+D+O v SoC in the Non-tbRCAm patients is a primary endpoint. SoC+D v SoC is reported separately as a secondary endpoint. Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
95% Confidence Interval
Months
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until primary analysis - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
Primary
Progression-free Survival (PFS) by Investigator Assessment Using Modified RECIST 1.1 - (Full Analysis Set, HRD Positive)
To determine the efficacy of durvalumab and olaparib assessed by PFS in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Per MTP, the comparison of SoC+D+O v SoC in the Non-tBRCAm HRD positve population is a primary endpoint. SoC+D v SoC is reported separately as a secondary endpoint. Results for tBRCAm SoC+D+O are not presented as as this was prespecified to be assessed only in the Non-tBRCAm patients.
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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
95% Confidence Interval
Months
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Assessed until DCO1 - (05DEC2022 for Global cohort, 17MAR2025 for China cohort) - upto 46 months
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D+O
Secondary
Time to Second Progression or Death Based on Local Standard Clinical Practice (PFS2) - (Full Analysis Set, HRD-positive)
To assess the efficacy of durvalumab and olaparib in terms of PFS2 in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to second progression or death (PFS2) is defined as the time from the date of randomisation/allocation to the earliest of the progression event subsequent to first subsequent therapy or death.
Results for tBRCAm SoC+D+O are not presented as this was prespecified to be assessed only in the Non-tBRCAm patients.
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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
95% Confidence Interval
Months
Assessed every 12 weeks after RECIST 1.1 defined progression. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - 46 months.
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Secondary
Objective Response Rate Based on Investigator Assessment (Full Analysis Set)
To assess the efficacy of durvalumab and olaparib in terms of ORR (Complete Response + Partial Response) by investigator assessment by modified RECIST 1.1:
in all patients with evaluable disease at baseline
prior to surgery in those patients planned to have IDS with evaluable disease at baseline.
Objective response rate (ORR) is defined similarly for the non-tBRCAm and tBRCAm cohorts as the number (percentage) of patients with at least one investigator-assessed visit response of CR or PR and will be based on a subset of all randomised/allocated patients who have evaluable disease at baseline per the site investigator.
All participants with measurable disease at baseline were included in the analysis. 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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Number
Percentage of participants
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for Global tBRCAm (DCO1 05DEC2022) and China (DCO1 17MAR2025)
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
Secondary
Objective Response Rate Based on Investigator Assessment (Full Analysis Set, HRD-positive)
To assess the efficacy of durvalumab and olaparib in terms of ORR (Complete Response + Partial Response) by investigator assessment by modified RECIST 1.1
in all patients with evaluable disease at baseline
prior to surgery in those patients planned to have IDS with evaluable disease at baseline.
Objective response rate (ORR) is defined similarly for the non-tBRCAm and tBRCAm cohorts as the number (percentage) of patients with at least one investigator-assessed visit response of CR or PR and will be based on a subset of all randomised/allocated patients who have evaluable disease at baseline per the site investigator.
This was prespecified to be assessed only in the non-tBRCAm cohort.
All participants with measurable disease at baseline were included in the analysis. 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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Number
Percentage of participants
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for China (DCO1 17MAR2025)
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
Secondary
Duration of Objective Response Based on Investigator Assessments (Full Analysis Set)
To assess the efficacy of durvalumab and olaparib in terms of duration of response (DoR) in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Duration of response (DoR) is defined similarly for the non-tBRCAm and tBRCAm cohorts using the corresponding FAS among patients with a response (CR or PR), as the time from the date of first documented response (i.e., the first time at which the visit response is PR or CR) according to modified RECIST v1.1 as assessed by the investigator until date of documented progression or death in the absence of disease progression.
This was prespecified to be assessed only in the Global patients.
All participants with confirmed response were included in the analysis. 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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
Inter-Quartile Range
Months
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023). Up to 46 for Global tBRCAm (DCO1 05DEC2022)
ID
Title
Description
OG000
Global Non-tBRCAm - SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
Secondary
Duration of Objective Response Based on Investigator Assessments (Full Analysis Set, HRD-positive)
To assess the efficacy of durvalumab and olaparib in terms of duration of response (DoR) in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Duration of response (DoR) is defined similarly for the non-tBRCAm and tBRCAm cohorts using the corresponding FAS among patients with a response (CR or PR), as the time from the date of first documented response (i.e., the first time at which the visit response is PR or CR) according to modified RECIST v1.1 as assessed by the investigator until date of documented progression or death in the absence of disease progression.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
All participants with confirmed response were included in the analysis. 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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
Inter-Quartile Range
Months
At baseline, within 3 weeks of last dose of chemotherapy, then every 12 weeks for 3 years and thereafter every 24 weeks. Up to 55 months for global non-tBRCAm (DCO2 18SEP2023).
ID
Title
Description
OG000
Global Non-tBRCAm - SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
Secondary
Time to First Subsequent Therapy (TFST) - Full Analysis Set
To assess the efficacy of durvalumab and olaparib in terms of TFST in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to start of first subsequent therapy or death (TFST) is defined as the time from randomisation/allocation to the earlier of first subsequent therapy start date following study treatment discontinuation, or death.
This was prespecified to be assessed only in Non-tBRCAm patients.
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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
95% Confidence Interval
Months
Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
Secondary
Time to First Subsequent Therapy (TFST) - (Full Analysis Set, HRD-positive)
To assess the efficacy of durvalumab and olaparib in terms of TFST in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to start of first subsequent therapy or death (TFST) is defined as the time from randomisation/allocation to the earlier of first subsequent therapy start date following study treatment discontinuation, or death.
This was prespecified to be assessed only in Non-tBRCAm patients.
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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
95% Confidence Interval
Months
Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
Secondary
Time to Second Subsequent Therapy (TSST) - Full Analysis Set
To assess the efficacy of durvalumab and olaparib in terms of TSST in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to second subsequent therapy or death (TSST) is defined as the time from randomisation/allocation to the earlier of the second subsequent anti-cancer therapy start date following study treatment discontinuation, or death.
This was prespecified to be assessed only in Non-tBRCAm patients.
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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
95% Confidence Interval
Months
Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
Secondary
Time to Second Subsequent Therapy (TSST) - (Full Analysis Set, HRD-positive)
To assess the efficacy of durvalumab and olaparib in terms of TSST in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to second subsequent therapy or death (TSST) is defined as the time from randomisation to the earlier of the second subsequent anti-cancer therapy start date following study treatment discontinuation, or death.
This was prespecified to be assessed only in Non-tBRCAm patients.
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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
95% Confidence Interval
Months
Assessed every 12 weeks following treatment discontinuation. For global cohort, assessed until DCO3 (17MAR2025) - up to 73 months. For China cohort assessed until DCO1 (17MAR2025) - up to 46 months.
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
Secondary
Time to Treatment Discontinuation (TDT) - Full Analysis Set
To assess the efficacy of durvalumab and olaparib in terms of TDT in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to permanent study treatment discontinuation or death (TDT) is defined as the time from randomisation/allocation to the earlier of the date of permanent study treatment discontinuation or death.
This was prespecified to be assessed only in Non-tBRCAm patients.
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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
95% Confidence Interval
Months
Assessed through study completion, up to 73 months for global non-tBRCAm (DCO3 17MAR2025) and up to 46 months for and China (DCO1 17MAR2025)
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
Secondary
Time to Treatment Discontinuation (TDT) - (Full Analysis Set, HRD-positive)
To assess the efficacy of durvalumab and olaparib in terms of TDT in the first line treatment of patients with newly diagnosed advanced ovarian cancer.
Time to permanent study treatment discontinuation or death (TDT) is defined as the time from randomisation/allocation to the earlier of the date of permanent study treatment discontinuation or death.
This was prespecified to be assessed only in Non-tBRCAm patients.
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 17 June 2021). China FAS includes all patients who were randomised at sites in China.
Posted
Median
95% Confidence Interval
Months
Assessed through study completion, up to 73 months for global non-tBRCAm (DCO3 17MAR2025) and up to 46 months for and China (DCO1 17MAR2025)
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
Secondary
Change From Baseline in Physical Function Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - Full Analysis Set
To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
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 17 June 2021).
Posted
Least Squares Mean
Standard Error
Score on a scale
Assessed at week 96.
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
Secondary
Change From Baseline in Physical Function Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - (Full Analysis Set, HRD Positive)
To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. The physical functioning score is a score from 0 to 100. Higher scores on the physical functioning score indicate better health status/function.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
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 17 June 2021).
Posted
Least Squares Mean
Standard Error
Score on a scale
Assessed at week 96.
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
Secondary
Change From Baseline in Global Health Status/QoL Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - Full Analysis Set
To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. 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.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
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 17 June 2021).
Posted
Least Squares Mean
Standard Error
Score on a scale
Assessed at week 96.
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
Secondary
Change From Baseline in Global Health Status/QoL Score of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 Questionnaires - (Full Analysis Set, HRD Positive)
To determine the effects on HRQoL, global health status and ovarian cancer symptoms of the combination of durvalumab and olaparib in the first line treatment of non-tBRCAm patients with newly diagnosed advanced ovarian cancer. 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.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
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 17 June 2021).
Posted
Least Squares Mean
Standard Error
Score on a scale
Assessed at week 96
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
Secondary
Summary of Serum Concentrations (μg/mL) of Durvalumab for Each Treatment - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (Pharmacokinetic Analysis Set)
To characterize the PK of durvalumab in combination with bevacizumab and olaparib.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
The PK analysis set comprises of all evaluable patients (a subset of those in the full analysis set) dosed with SoC + durvalumab or SoC + durvalumab + olaparib and providing at least one post-dose analysable concentration of durvalumab and/or olaparib.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Assessed at Day 85 pre-dose, Day 183 pre-dose and 3 months after last dose of durvalumab.
ID
Title
Description
OG000
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG001
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Secondary
Summary of Plasma Concentrations (μg/mL) of Olaparib - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (Pharmacokinetic Analysis Set)
To determine olaparib plasma concentrations via sparse sampling for population PK analyses.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
The PK analysis set comprises of all evaluable patients (a subset of those in the full analysis set) dosed with SoC + durvalumab + olaparib and providing at least one post-dose analysable concentration of olaparib.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Assessed on Day 148 post-dose (1-3 hours, 3-6 hours and 6-12 hours)
ID
Title
Description
OG000
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000
Secondary
Summary of ADA Responses During the Study for Durvalumab - Non-tBRCAm Cohort With Primary Cytoreductive Surgery (ADA Analysis Set)
To characterize the immunogenicity of durvalumab in combination with bevacizumab and olaparib.
This was prespecified to be assessed only in Global Non-tBRCAm patients.
The ADA evaluable subjects are patients in the Safety Analysis Set who received at least 1 dose of durvalumab and have non-missing baseline ADA and at least 1 post-baseline ADA result.
Posted
Number
Number of participants
Assessed pre-infusion at Cycle 2, Cycle 4, Cycle 6 and the third cycle of the maintenance phase as well as 3 months after last dose of durvalumab
ID
Title
Description
OG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG002
Global Non-tBRCAm: SoC+D+O
Time Frame
For global cohort, assessed from date of first subject randomised until DCO3 (17MAR2025) - 6 years 1 month. For China cohort assessed from date of first subject randomised until DCO1 (17MAR2025) - 3 years 10 months.
Description
Deaths analysed in FAS; AEs analysed in all randomised patients who received study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Global Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
205
378
132
376
369
376
EG001
Global Non-tBRCAm: SoC + Durvalumab
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
200
374
165
373
367
373
EG002
Global Non-tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
193
378
152
378
372
378
EG003
Global tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
47
154
74
153
151
153
EG004
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
14
40
19
40
40
40
EG005
China Non-tBRCAm: SoC + Durvalumab
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
11
43
17
43
43
43
EG006
China Non-tBRCAm: SoC + Durvalumab + Olaparib
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
7
41
22
41
41
41
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Intestinal perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0013 events3 affected373 at risk
EG0023 events3 affected378 at risk
EG0031 events1 affected153 at risk
EG0040 events0 affected40 at risk
EG0050 events0 affected43 at risk
EG0060 events0 affected41 at risk
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Mechanical ileus
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Myelosuppression
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0022 events2 affected378 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Rectal discharge
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0017 events4 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Small intestinal perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected376 at risk
EG0012 events2 affected373 at risk
EG0025 events4 affected378 at risk
EG003
Superior mesenteric artery syndrome
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected376 at risk
EG0011 events1 affected373 at risk
EG0029 events8 affected378 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0022 events2 affected378 at risk
EG003
Administration site extravasation
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Asthenia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Dehiscence
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0012 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Extravasation
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
General physical health deterioration
General disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected376 at risk
EG0013 events3 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Hernia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0023 events3 affected378 at risk
EG003
Incarcerated hernia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Performance status decreased
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0006 events5 affected376 at risk
EG0013 events3 affected373 at risk
EG00215 events10 affected378 at risk
EG003
Paratracheal lymphadenopathy
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Biloma
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Biloma rupture
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0012 events2 affected373 at risk
EG0022 events2 affected378 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Reticulocytosis
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0012 events2 affected373 at risk
EG0023 events2 affected378 at risk
EG003
Hepatitis acute
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Suspected drug-induced liver injury
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Anaphylactic shock
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0015 events5 affected373 at risk
EG0022 events2 affected378 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0013 events3 affected373 at risk
EG0023 events3 affected378 at risk
EG003
Sarcoidosis
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Abdominal sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0012 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0022 events2 affected378 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0013 events3 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Bronchopulmonary aspergillosis allergic
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Covid-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected376 at risk
EG0017 events7 affected373 at risk
EG0028 events8 affected378 at risk
EG003
Covid-19 pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Campylobacter infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Catheter site infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0013 events3 affected373 at risk
EG0023 events1 affected378 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Device related infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0013 events2 affected373 at risk
EG0022 events2 affected378 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Enterocolitis bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Gastroenteritis bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected376 at risk
EG0013 events2 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Hepatitis e
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Human anaplasmosis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Infected lymphocele
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Infected seroma
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Joint abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0006 events5 affected376 at risk
EG0013 events3 affected373 at risk
EG00217 events12 affected378 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected376 at risk
EG0012 events2 affected373 at risk
EG0023 events3 affected378 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0025 events5 affected378 at risk
EG003
Pneumonia cytomegaloviral
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Psoas abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Atrial thrombosis
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected376 at risk
EG0015 events5 affected373 at risk
EG0026 events6 affected378 at risk
EG003
Septic shock
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Superinfection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Suspected covid-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00011 events8 affected376 at risk
EG0017 events6 affected373 at risk
EG0029 events9 affected378 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0012 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Vulval abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Wound infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Wound infection staphylococcal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Anaemia postoperative
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0012 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Anastomotic fistula
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Anastomotic leak
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Diversion colitis
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Gastrointestinal stoma complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0023 events1 affected378 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Incarcerated incisional hernia
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0015 events5 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0012 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Pneumoconiosis
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Postoperative adhesion
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Postoperative ileus
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Postoperative lymphocele
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Procedural complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Procedural intestinal perforation
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Scar
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Seroma
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Stoma complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Stoma site dermatitis
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Stoma site pain
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Subcutaneous haematoma
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Traumatic haemorrhage
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0022 events2 affected378 at risk
EG003
Vaginal cuff dehiscence
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Vulvovaginal injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected376 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Wound evisceration
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Amylase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Hypertensive heart disease
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Lipase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Liver function test increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Mean cell volume increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0023 events2 affected378 at risk
EG003
Norovirus test positive
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Pancreatic enzymes increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0012 events2 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Aplasia pure red cell
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0022 events2 affected378 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected376 at risk
EG0012 events2 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Fistula discharge
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Immobilisation syndrome
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Immune-mediated arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Osteoporotic fracture
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Acute myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Adenocarcinoma pancreas
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Cholangiocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0021 events1 affected378 at risk
EG003
Diffuse large b-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0011 events1 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected376 at risk
EG0010 events0 affected373 at risk
EG0022 events2 affected378 at risk
EG003
Renal perivascular epithelioid cell tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected376 at risk
EG0010 events0 affected373 at risk
EG0020 events0 affected378 at risk
EG003
Tubular breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D000091662
Genital Diseases
D004700
Endocrine System Diseases
D006058
Gonadal Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068258
Bevacizumab
C000613593
durvalumab
C531550
olaparib
C053518
CP protocol
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0051 subjects
FG0060 subjects
FG004
0 subjects
FG0050 subjects
FG0060 subjects
55.7
± 10.3
BG00458.8± 8.6
BG00552.8± 8.7
BG00653.9± 9.4
BG00758.4± 10.4
135
BG00337
BG00410
BG0054
BG0065
BG007427
<65
Title
Measurements
BG000268
BG001248
BG002243
BG003117
BG00430
BG00539
BG00636
BG007981
378
BG003154
BG00440
BG00543
BG00641
BG0071408
25
BG0035
BG0040
BG0050
BG0060
BG00779
Not Hispanic or Latino
BG000345
BG001347
BG002346
BG003149
BG00440
BG00543
BG00641
BG0071311
Unknown or Not Reported
BG0004
BG0017
BG0027
BG0030
BG0040
BG0050
BG0060
BG00718
1
BG0031
BG0040
BG0050
BG0060
BG00710
ASIAN
Title
Measurements
BG00055
BG00152
BG00247
BG00345
BG00440
BG00543
BG00641
BG007323
BLACK OR AFRICAN AMERICAN
Title
Measurements
BG0003
BG0013
BG0024
BG0031
BG0040
BG0050
BG0060
BG00711
MISSING
Title
Measurements
BG0001
BG0016
BG0021
BG0030
BG0040
BG0050
BG0060
BG0078
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
OTHER
Title
Measurements
BG00023
BG00116
BG00219
BG0031
BG0040
BG0050
BG0060
BG00759
WHITE
Title
Measurements
BG000292
BG001293
BG002306
BG003106
BG0040
BG0050
BG0060
BG007997
43
21.7
(12.4 to NA)
Insufficient number of events to estimate upper limit.
China cohort designed to provide descriptive analysis only.
Hazard Ratio (HR)
0.80
2-Sided
95
0.45
1.40
A HR less than 1 favours SoC+D
Superiority
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG003
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG004
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG005
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000378
OG001374
OG002378
OG00340
OG00443
OG00541
Title
Denominators
Categories
Title
Measurements
OG00049.6(45.8 to 57.8)
OG00148.5(43.6 to 59.0)
OG00250.5(45.2 to 65.1)
OG003NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
OG00443.2(34.1 to NA)Insufficient number of events to estimate upper limit.
OG005NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Log Rank
The p-value is calculated using an unstratified log rank test.
0.3781
Hazard Ratio (HR)
0.92
2-Sided
95
0.75
1.11
A HR less than 1 favours SoC+D+O
Superiority
OG000
OG001
Hazard Ratio (HR)
0.97
2-Sided
95
0.80
1.18
A HR less than 1 favours SoC+D
Superiority
OG003
OG005
China cohort designed to provide descriptive analysis only.
Hazard Ratio (HR)
0.42
2-Sided
95
0.16
1.00
A HR less than 1 favours SoC+D+O
Superiority
OG003
OG004
China cohort designed to provide descriptive analysis only.
Hazard Ratio (HR)
0.70
2-Sided
95
0.31
1.53
A HR less than 1 favours SoC+D
Superiority
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG003
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG004
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG005
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000143
OG001148
OG002140
OG00320
OG00430
OG00528
Title
Denominators
Categories
Title
Measurements
OG00066.8(60.9 to NA)Insufficient number of events to estimate upper limit.
OG001NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
OG002NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
OG003NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
OG004NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
OG005NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard Ratio (HR)
0.80
2-Sided
95
0.54
1.18
A HR less than 1 favours SoC+D+O
Superiority
OG003
OG005
Hazard Ratio (HR)
0.41
2-Sided
95
0.12
1.30
A HR less than 1 favours SoC+D+O
Superiority
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG003
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG004
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG005
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000378
OG001374
OG002378
OG00340
OG00443
OG00541
Title
Denominators
Categories
Title
Measurements
OG00032.6(30.7 to 35.4)
OG00134.6(30.2 to 37.7)
OG00236.9(32.7 to 41.1)
OG00327.5(19.8 to NA)Insufficient number of events to estimate upper limit.
OG00428.8(22.6 to NA)Insufficient number of events to estimate upper limit.
OG005NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard Ratio (HR)
0.78
2-Sided
95
0.65
0.93
A HR less than 1 favours SoC+D+O
Superiority
OG000
OG001
Hazard Ratio (HR)
0.89
2-Sided
95
0.74
1.06
A HR less than 1 favours SoC+D
Superiority
OG003
OG005
Hazard Ratio (HR)
0.38
2-Sided
95
0.14
0.90
A HR less than 1 favours SoC+D+O
Superiority
OG003
OG004
Hazard Ratio (HR)
0.97
2-Sided
95
0.48
1.96
A HR less than 1 favours SoC+D
Superiority
OG001
Global Non-tBRCAm: SoC+D+O
Patients will receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG002
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG003
China Non-tBRCAm: SoC+D+O
Patients will receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000378
OG001378
OG00240
OG00341
Title
Denominators
Categories
Title
Measurements
OG00019.3(17.9 to 20.3)
OG00124.2(22.7 to 26.8)
OG00217.4(11.7 to 26.4)
OG00326.8(23.5 to NA)Insufficient number of events to estimate upper limit.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
<0.0001
The p-value is calculated using a log rank test stratified by timing and outcome of cytoreductive surgery' and 'geographic region'.
Hazard Ratio (HR)
0.63
2-Sided
95
0.52
0.76
A HR less than 1 favours SoC+D+O.
Superiority
OG002
OG003
China cohort designed to provide descriptive analysis only.
Hazard Ratio (HR)
0.47
2-Sided
95
0.25
0.86
A HR less than 1 favours SoC+D+O.
Superiority
Patients will receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG002
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG003
China Non-tBRCAm: SoC+D+O
Patients will receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000143
OG001140
OG00220
OG00328
Title
Denominators
Categories
Title
Measurements
OG00023(21.2 to 24.8)
OG00137.3(29.8 to NA)Insufficient number of events to estimate upper limit.
OG00215.6(9.3 to 23.9)
OG00326.8(23.5 to NA)Insufficient number of events to estimate upper limit.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
<0.0001
The p-value is calculated using a log rank test stratified by timing and outcome of cytoreductive surgery'.
Hazard Ratio (HR)
0.49
2-Sided
95
0.34
0.69
A HR less than 1 favours SoC+D+O.
Superiority
OG002
OG003
China cohort designed to provide descriptive analysis only.
Hazard Ratio (HR)
0.39
2-Sided
95
0.17
0.86
A HR less than 1 favours SoC+D+O
Superiority
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG003
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG004
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG005
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000143
OG001148
OG002140
OG00320
OG00430
OG00528
Title
Denominators
Categories
Title
Measurements
OG00042.4(38.8 to 58.9)
OG00151.3(40.8 to NA)Insufficient number of events to estimate upper limit.
OG002NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
OG003NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
OG00434.1(22.2 to NA)Insufficient number of events to estimate upper limit.
OG005NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard Ratio (HR)
0.65
2-Sided
95
0.46
0.92
A HR less than 1 favours SoC+D+O
Superiority
OG003
OG005
Hazard Ratio (HR)
0.37
2-Sided
95
0.11
1.16
A HR less than 1 favours SoC+D+O
Superiority
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG003
Global tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG004
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG005
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG006
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000296
OG001288
OG002296
OG003117
OG00426
OG00530
OG00627
Title
Denominators
Categories
Title
Measurements
OG00070.3
OG00168.1
OG00274.3
OG00372.6
OG00457.7
OG00556.7
OG00666.7
OG001
Global Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG003
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG004
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG005
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000108
OG001107
OG002103
OG00316
OG00421
OG00518
Title
Denominators
Categories
Title
Measurements
OG00082.4
OG00173.8
OG00285.4
OG00356.3
OG00471.4
OG00566.7
OG001
Global Non-tBRCAm - SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG002
Global Non-tBRCAm - SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG003
Global tBRCAm - SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000208
OG001196
OG002220
OG003154
Title
Denominators
Categories
Title
Measurements
OG00016.4(8.3 to 23.8)
OG00115.9(8.4 to 28.3)
OG00222.3(12.1 to NA)Insufficient DoR events to estimate upper confidence limit.
OG003NA(24.9 to NA)Median and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
OG001
Global Non-tBRCAm - SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG002
Global Non-tBRCAm - SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG00089
OG00179
OG00288
Title
Denominators
Categories
Title
Measurements
OG00019.4(12.5 to 47.8)
OG00119.3(11.5 to 34.5)
OG00231.3(18.4 to NA)Insufficient DoR events to estimate upper confidence limit.
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG003
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG004
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG005
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000378
OG001374
OG002378
OG00340
OG00443
OG00541
Title
Denominators
Categories
Title
Measurements
OG00021.6(20.1 to 23.4)
OG00121.9(19.8 to 23.4)
OG00226.3(24.2 to 29.5)
OG00319.0(12.4 to 27.6)
OG00421.7(15.6 to NA)Insufficient number of events to estimate upper limit.
OG005NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard Ratio (HR)
0.68
2-Sided
95
0.58
0.80
A HR less than 1 favours SoC+D+O
Superiority
OG000
OG001
Hazard Ratio (HR)
0.87
2-Sided
95
0.74
1.03
A HR less than 1 favours SoC+D
Superiority
OG003
OG005
Hazard Ratio (HR)
0.47
2-Sided
95
0.25
0.86
A HR less than 1 favours SoC+D+O
Superiority
OG003
OG004
Hazard Ratio (HR)
0.87
2-Sided
95
0.50
1.52
A HR less than 1 favours SoC+D
Superiority
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG003
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG004
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG005
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000143
OG001148
OG002140
OG00320
OG00430
OG00528
Title
Denominators
Categories
Title
Measurements
OG00025.8(23.5 to 30.9)
OG00129.0(25.1 to 39.2)
OG00241.4(33.2 to 59.2)
OG00317.9(11.7 to NA)Insufficient number of events to estimate upper limit.
OG00434.1(16.8 to NA)Insufficient number of events to estimate upper limit.
OG005NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard Ratio (HR)
0.57
2-Sided
95
0.42
0.77
A HR less than 1 favours SoC+D+O
Superiority
OG003
OG005
Hazard Ratio (HR)
0.48
2-Sided
95
0.21
1.06
A HR less than 1 favours SoC+D+O
Superiority
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG003
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG004
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG005
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000378
OG001374
OG002378
OG00340
OG00443
OG00541
Title
Denominators
Categories
Title
Measurements
OG00033.1(31.6 to 36.6)
OG00134.9(31.8 to 37.8)
OG00238.5(34.6 to 42.1)
OG003NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
OG00430.6(22.2 to NA)Insufficient number of events to estimate upper limit.
OG005NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard Ratio (HR)
0.79
2-Sided
95
0.65
0.94
A HR less than 1 favours SoC+D+O
Superiority
OG000
OG001
Hazard Ratio (HR)
0.93
2-Sided
95
0.78
1.12
A HR less than 1 favours SoC+D
Superiority
OG003
OG005
Hazard Ratio (HR)
0.36
2-Sided
95
0.14
0.85
A HR less than 1 favours SoC+D+O
Superiority
OG003
OG004
Hazard Ratio (HR)
0.98
2-Sided
95
0.49
1.99
A HR less than 1 favours SoC+D
Superiority
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG003
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG004
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG005
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000143
OG001148
OG002140
OG00320
OG00430
OG00528
Title
Denominators
Categories
Title
Measurements
OG00046.8(39.5 to 60.0)
OG00148.4(41.8 to NA)Insufficient number of events to estimate upper limit.
OG002NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
OG003NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
OG00434.1(22.2 to NA)Insufficient number of events to estimate upper limit.
OG005NA(NA to NA)Median, lower and upper limits of the 95% Confidence Interval not reached due to insufficient number of participants with events
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard Ratio (HR)
0.67
2-Sided
95
0.47
0.96
A HR less than 1 favours SoC+D+O
Superiority
OG003
OG005
Hazard Ratio (HR)
0.36
2-Sided
95
0.11
1.14
A HR less than 1 favours SoC+D+O
Superiority
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG003
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG004
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG005
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000378
OG001374
OG002378
OG00340
OG00443
OG00541
Title
Denominators
Categories
Title
Measurements
OG00018.4(17.1 to 19.7)
OG00117.5(15.2 to 19.4)
OG00220.4(18.5 to 21.7)
OG00314.8(10.4 to 23.0)
OG00414.5(9.0 to 22.4)
OG00522.0(15.4 to 26.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard Ratio (HR)
0.88
2-Sided
95
0.76
1.02
A HR less than 1 favours SoC+D+O
Superiority
OG000
OG001
Hazard Ratio (HR)
0.98
2-Sided
95
0.85
1.13
A HR less than 1 favours SoC+D
Superiority
OG003
OG005
Hazard Ratio (HR)
0.82
2-Sided
95
0.50
1.34
A HR less than 1 favours SoC+D+O
Superiority
OG003
OG004
Hazard Ratio (HR)
0.86
2-Sided
95
0.52
1.43
A HR less than 1 favours SoC+D
Superiority
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
OG003
China Non-tBRCAm: SoC
Patients receive saline IV Q3W as a placebo for durvalumab from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months.
OG004
China Non-tBRCAm: SoC+D
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive placebo tablets, matched to olaparib for up to a total of 24 months
OG005
China Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000143
OG001148
OG002140
OG00320
OG00430
OG00528
Title
Denominators
Categories
Title
Measurements
OG00022.0(20.5 to 24.9)
OG00122.3(19.4 to 24.3)
OG00224.7(21.9 to 27.5)
OG00315.7(9.2 to 24.0)
OG00420.0(11.8 to NA)Insufficient number of events to estimate upper limit.
OG00521.8(14.6 to 26.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Hazard Ratio (HR)
0.84
2-Sided
95
0.66
1.06
A HR less than 1 favours SoC+D+O
Superiority
OG003
OG005
Hazard Ratio (HR)
0.77
2-Sided
95
0.40
1.49
A HR less than 1 favours SoC+D+O
Superiority
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000378
OG001374
OG002378
Title
Denominators
Categories
Title
Measurements
OG0006.3± 1.30
OG0013.3± 1.25
OG0023.0± 1.31
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
LS mean difference
-3.2
2-Sided
95
-6.73
0.27
Analyses of QLQ-C30/QLQ-OV28 scores were performed using linear random coefficient mixed models with nodes set at scheduled assessment days.
Superiority
OG001
OG002
LS Mean difference
-3.0
2-Sided
95
-6.42
0.44
Analyses of QLQ-C30/QLQ-OV28 scores were performed using linear random coefficient mixed models with nodes set at scheduled assessment days.
Superiority
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000143
OG001148
OG002140
Title
Denominators
Categories
Title
Measurements
OG0009.8± 1.53
OG0014.9± 1.88
OG0027.6± 1.61
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
LS mean difference
-2.2
2-Sided
95
-6.42
1.92
Analyses of QLQ-C30/QLQ-OV28 scores were performed using linear random coefficient mixed models with nodes set at scheduled assessment days.
Superiority
OG001
OG002
LS Mean difference
-4.9
2-Sided
95
-9.51
-0.27
Analyses of QLQ-C30/QLQ-OV28 scores were performed using linear random coefficient mixed models with nodes set at scheduled assessment days.
Superiority
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000378
OG001374
OG002378
Title
Denominators
Categories
Title
Measurements
OG0006.3± 1.23
OG0013.8± 1.33
OG0024.6± 1.19
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
LS mean difference
-1.7
2-Sided
95
-4.96
1.47
Analyses of QLQ-C30/QLQ-OV28 scores were performed using linear random coefficient mixed models with nodes set at scheduled assessment days.
Superiority
OG001
OG002
LS Mean difference
-2.5
2-Sided
95
-5.89
0.90
Analyses of QLQ-C30/QLQ-OV28 scores were performed using linear random coefficient mixed models with nodes set at scheduled assessment days.
Superiority
OG002
Global Non-tBRCAm: SoC+D+O
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG000143
OG001148
OG002140
Title
Denominators
Categories
Title
Measurements
OG0008.5± 1.75
OG0016.3± 1.97
OG0027.0± 1.64
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
LS mean difference
-1.5
2-Sided
95
-6.02
2.96
Analyses of QLQ-C30/QLQ-OV28 scores were performed using linear random coefficient mixed models with nodes set at scheduled assessment days.
Superiority
OG001
OG002
LS Mean difference
-2.3
2-Sided
95
-7.27
2.75
Analyses of QLQ-C30/QLQ-OV28 scores were performed using linear random coefficient mixed models with nodes set at scheduled assessment days.
Superiority
Units
Counts
Participants
OG00071
OG00192
Title
Denominators
Categories
Day 85, pre-dose
Title
Measurements
OG000218376.482± 40.8
OG001207988.974± 30.1
Day 148, pre-dose
Title
Measurements
OG000237360.027± 36.8
OG001252257.020± 39.9
Follow-up (3 months after last dose of durvalumab.)
Title
Measurements
OG00038355.597± 112.3
OG00125776.441± 218.4
92
Title
Denominators
Categories
Day 148, 1-3 hours
Title
Measurements
OG0005.8563± 47.7
Day 148, 3-6 hours
Title
Measurements
OG0004.2425± 38.4
Day 148, 6-12 hours
Title
Measurements
OG0002.5059± 44.2
Patients receive durvalumab 1120 mg Q3W from Day 1 of Cycle 2 for up to a total of 35 cycles (24 months) of treatment. At the end of chemotherapy, patients will also receive olaparib tablets, 300 mg twice daily (bd) for up to a total of 24 months.
Units
Counts
Participants
OG00058
OG00174
OG002132
Title
Denominators
Categories
ADA positive at any visit (ADA Prevalence)
Title
Measurements
OG0004
OG0012
OG0026
Treatment-emergent ADA-positive (ADA incidence)
Title
Measurements
OG0001
OG0010
OG0021
Treatment-boosted ADA
Title
Measurements
OG0000
OG0010
OG0020
Treatment-induced ADA (Positive Post-baseline only)
Title
Measurements
OG0001
OG0010
OG0021
ADA positive at baseline only
Title
Measurements
OG0003
OG0012
OG0025
ADA Positive Post-baseline and Positive at Baseline