A Phase I/II Study of MEDI4736 in Combination With Olapar... | NCT02734004 | Trialant
NCT02734004
Sponsor
AstraZeneca
Status
Active, not recruiting
Last Update Posted
Apr 20, 2026Actual
Enrollment
264Actual
Phase
Phase 1Phase 2
Conditions
Ovarian
Breast
SCLC
Gastric Cancers
Interventions
Olaparib
MEDI4736
Bevacizumab
Countries
United States
France
Israel
Netherlands
South Korea
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02734004
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D081KC00001
Secondary IDs
ID
Type
Description
Link
2015-004005-16
EudraCT Number
Brief Title
A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.
Official Title
A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors
Acronym
MEDIOLA
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Apr 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
YesNCT03079687Approved for marketing
Start Date
Mar 17, 2016Actual
Primary Completion Date
Sep 17, 2021Actual
Completion Date
Sep 17, 2026Estimated
First Submitted Date
Mar 17, 2016
First Submission Date that Met QC Criteria
Apr 6, 2016
First Posted Date
Apr 12, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 14, 2022
Results First Submitted that Met QC Criteria
Oct 12, 2023
Results First Posted Date
Oct 13, 2023Actual
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
Apr 17, 2026
Last Update Posted Date
Apr 20, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Name
Class
IQVIA Pty Ltd
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to look at the effectiveness, safety, and antitumor activity of study drugs MEDI4736 in combination with olaparib (modules 1, 2, 3, 4, 5 and 7) and MEDI4736 in combination with olaparib and bevacizumab (module 6). It will also examine what happens to the study drugs in the body and investigate how well the combination between MEDI4736, olaparib and bevacizumab is tolerated.
Detailed Description
This is a phase I/II open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK) and antitumor activity of MEDI4736 in combination with olaparib in patients with advanced solid tumors, selected based on a rationale for response to olaparib.
Patients will be poly (adenosine diphosphate-ribose) polymerase (PARP)-inhibitor and immunotherapy (IMT)-naïve (defined as no prior exposure to PARP inhibitors or IMT, including, but not limited to, other anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], anti-programmed cell death 1 [PD-1], anti-programmed death-ligand 1 [PD-L1] monoclonal antibodies, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
The 4 initial stage cohorts (Modules 1 to 4) include patients with relapsed small cell lung cancer (SCLC), germline BRCA mutated (gBRCAm) metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer, gBRCAm platinum-sensitive relapsed ovarian cancer, and gastric cancer. The data cut-off occurred once all 4 Modules had reached last patient first visit (LPFV) + 2 years and all 4 cohorts had observed a median value for PFS.
Second stage cohorts (Modules 5 to 7) include patients with relapsed gBRCAm platinum-sensitive relapsed ovarian cancer and non gBRCAm platinum-sensitive relapsed ovarian cancer. The final data cut-off will be once Modules 6 and 7 have observed a median value for overall survival. At this timepoint, the clinical study database will close to new data.
Conditions Module
Conditions
Ovarian
Breast
SCLC
Gastric Cancers
Keywords
MEDIOLA
Olaparib
MEDI4736
Bevacizumab
Ovarian cancer
Breast cancer
Small Cell Lung Cancer
Gastric Cancer
Phase I/II, Adults
PDL-1
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
264Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Arm 1
Experimental
Includes initial stage cohorts (modules 1 to 4): Olaparib twice daily starting on week 1 day 1 and MEDI4736 every 4 weeks starting on week 5 day 1
Drug: Olaparib
Drug: MEDI4736
Arm 2
Experimental
Includes 2nd stage cohorts (modules 5 & 7): Olaparib twice daily starting on week 1 day 1 and MEDI4736 every 4 weeks starting on week 1 day 1
Drug: Olaparib
Drug: MEDI4736
Arm 3
Experimental
Includes 2nd stage cohort (module 6): Olaparib twice daily starting on week 1 day 1 / MEDI4736 every 4 weeks starting on week 1 day 1 / Bevacizumab every 2 weeks starting on week 1 day 1
Drug: Olaparib
Drug: MEDI4736
Drug: Bevacizumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Olaparib
Drug
Olaparib
Arm 1
Arm 2
Arm 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Initial Stage Cohorts: Disease Control Rate (DCR) at Week 12
The DCR at 12 weeks was defined as the percentage of participants who had complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks. Participants demonstrated SD for a minimum interval of 11 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 77 days) following the start of treatment. The DCR was determined using Investigator assessments according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.
Second Stage Cohort: Objective Response Rate (ORR)
The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% confidence interval (CI) were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion.
RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
Second Stage Cohorts: DCR at Week 24
The DCR at 24 weeks was defined as the percentage of participants who had CR + PR + SD at 24 weeks. Participants demonstrated SD for a minimum interval of 23 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.
RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
Secondary Outcomes
Measure
Description
Time Frame
Second Stage Expansion Cohort: DCR at Week 24
The DCR at 24 weeks was defined as the percentage of participants who had CR + PR + SD at 24 weeks. Participants demonstrated SD for a minimum interval of 23 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Patients must have histologically or cytologically confirmed progressive advanced or metastatic solid tumor of one of the following:
Platinum sensitive relapsed small cell lung cancer (module 1)
gBRCAm HER2-negative metastatic breast cancer (module 2)
gBRCAm ovarian cancer (modules 3 and 5)
Metastatic or relapsed Gastric cancer (adenocarcinoma) (module 4)
gBRCAm negative ovarian cancer (modules 6 and 7)
At least one measurable lesion that can be accurately assessed at baseline by computed tomography (CT) (or magnetic resonance imaging [MRI] suitable for assessment as per RECIST 1.1. The baseline scan must be obtained within 28 days prior to the first dose of olaparib.
Male or female patients, age ≥18 years (≥19 years for South Korea)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Life expectancy ≥12 weeks
Adequate organ and marrow function
Ability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation. Patients should not have gastrointestinal illnesses that would preclude the absorption of olaparib, which is an oral agent. For the gastric cancer cohort, patients with a full or partial gastrectomy will be permitted.
Ability of patient to understand and the willingness to sign a written informed consent document prior to any protocol related procedures, including screening evaluations.
Female patients must either:
Be of non-reproductive potential OR
Have a negative serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Day 1, and agree to use contraception if they or their partner are of reproductive potential
Exclusion criteria
Prior chemotherapy or other systemic anticancer therapy within 4 weeks prior to start of olaparib treatment, 6 weeks for nitrosoureas or mitomycin. Exceptions include: Anti-hormonal treatment for ER positive or PR positive breast cancer is allowed until 7 days prior to treatment with olaparib, exposure to an investigational agent within 30 days or 5 half-lives (whichever is the longer) prior to start of olaparib treatment is not allowed, prior receipt of biologics targeting T cell co-regulatory proteins and/or immune checkpoints is not allowed. Examples include MEDI4736 or other PD1 or PD-L1 or PD-L2 inhibitors or anti-CTLA4 therapy, previous treatment with a PARP inhibitor, is not allowed.
Radiation therapy within 4 weeks prior to start of olaparib treatment (includes radiation targeting bone metastases) or radionuclide treatment within 6 weeks of treatment start.
Current dependency on total parenteral nutrition or IV fluid hydration.
Concomitant use of known strong cytochrome P450 (CYP) 3A (CYP3A) inhibitors or moderate CYP3A inhibitors. Concomitant use of known strong or moderate CYP3A inducers.
Concomitant therapy with any other anticancer therapy or chronic use of systemic corticosteroids.
Previous allogenic bone marrow transplant or double umbilical cord blood transplantation
Whole blood transfusions in the last 120 days
Patients with symptomatic or uncontrolled brain metastases.
Patients being considered at poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease.
Any psychiatric disorder that prohibits obtaining informed consent
Major surgery or significant traumatic injury within 2 weeks of run-in
Immunocompromised patients
QTc prolongation >470 msec or other significant ECG abnormality noted within 14 days of treatment
Pregnant and breastfeeding women are excluded.
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Previous enrolment in the present study
Participation in a clinical study within 28 days or 5 half-lives of the drug, whichever is longer.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
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
Susan Domchek, MD
Abramson Cancer Center, University of Pennsylvania
Drew Y, Kim JW, Penson RT, O'Malley DM, Parkinson C, Roxburgh P, Plummer R, Im SA, Imbimbo M, Ferguson M, Rosengarten O, Steeghs N, Kim MH, Gal-Yam E, Tsoref D, Kim JH, You B, De Jonge M, Lalisang R, Gort E, Bastian S, Meyer K, Feeney L, Baker N, Ah-See ML, Domchek SM, Banerjee S; MEDIOLA Investigators. Olaparib plus Durvalumab, with or without Bevacizumab, as Treatment in PARP Inhibitor-Naive Platinum-Sensitive Relapsed Ovarian Cancer: A Phase II Multi-Cohort Study. Clin Cancer Res. 2024 Jan 5;30(1):50-62. doi: 10.1158/1078-0432.CCR-23-2249.
This study consists a screening period (28 days), run-in monotherapy treatment period (initial stage cohort only; 4 weeks) followed by combination therapy treatment period until progressive disease (PD). 148 participants entered initial stage cohorts and 114 participants entered second stage cohorts. Thus, 262 participants were enrolled in the study.
Recruitment Details
This Phase I/II open-label study was conducted in participants with advanced solid tumors at 43 centers in France, the United Kingdom, the Republic of Korea, the USA, the Netherlands, Israel, and Switzerland. Initial stage cohorts: Results are reported for analysis with assessment until data cut-off (DCO) of 14 Jun 2019 [except for overall survival (OS) for ovarian cancer cohort (DCO: 17 Sep 2021)]. Second stage cohorts: Results are reported for analysis with assessment until DCO of 17 Sep 2021.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 milligram (mg) orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 grams (g) intravenous (IV) infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
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
Dec 17, 2020
Sep 14, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
MEDI4736
Drug
MEDI4736
Arm 1
Arm 2
Arm 3
Bevacizumab
Drug
Bevacizumab
Arm 3
Avastin
RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
Initial Stage Cohorts: DCR at Week 28
The DCR at 28 weeks was defined as the percentage of participants who had CR + PR + SD at 28 weeks. Participants demonstrated SD for a minimum interval of 27 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 189 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.
RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.
Second Stage Cohorts: DCR at Week 56
The DCR at 56 weeks was defined as the percentage of participants who had CR + PR + SD at 56 weeks. Participants demonstrated SD for a minimum interval of 55 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 385 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.
RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
Initial and Second Stage Cohorts: ORR
The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% CI were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion.
RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Initial and Second Stage Cohorts: Duration of Response (DoR)
The DoR (based on RECIST 1.1 as assessed by the Investigator) was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. The DoR was calculated using Kaplan-Meier technique.
RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Initial and Second Stage Cohorts: Progression-Free Survival (PFS)
The PFS (based on RECIST 1.1 as assessed by the Investigator) was defined as the time from start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) until the date of objective PD or death (by any cause in the absence of disease progression) regardless of whether the patient withdraws from therapy or receives another anticancer therapy prior to disease progression. The PFS was calculated using Kaplan-Meier technique.
RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Initial Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 12 and 28
The percentage change in target tumor size at each timepoint (based on RECIST 1.1 target lesion measurements) was obtained for each participant taking the difference between the sum of the target lesions at each timepoint and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline times 100. Baseline was defined as the last evaluable assessment prior to starting olaparib treatment.
Baseline (Day 1) and Weeks 12 and 28. Assessed until DCO 14 Jun 2019
Second Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 24 and 56
The percentage change in target tumor size at each timepoint (based on RECIST 1.1 target lesion measurements) was obtained for each participant taking the difference between the sum of the target lesions at each timepoint and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline times 100. Baseline was defined as the last assessment prior to Cycle 1 Day 1.
Baseline (Day 1) and Weeks 24 and 56. Assessed until DCO 17 Sep 2021
Initial and Second Stage Cohorts: Best Percentage Change From Baseline in Target Tumor Size
The best percentage change from baseline in target tumor size was based on RECIST 1.1 target lesion measurements taken at each RECIST 1.1 assessment. All measurements until PD or the last evaluable assessment in the absence of PD was included in the calculation. Baseline was defined as the last evaluable assessment prior to starting olaparib treatment for initial stage cohorts. Baseline was defined as the last assessment prior to Cycle 1 Day 1 for second stage cohorts.
From baseline (Day 1) until confirmed PD/death. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Initial and Second Stage Cohorts: Time to Study Treatment Discontinuation or Death (TDT)
The TDT was defined as the time from start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) to the earlier of the date of study treatment discontinuation or death. The TDT was calculated using the Kaplan-Meier technique.
From baseline (Day 1) until treatment discontinuation/death. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Initial and Second Stage Cohorts: OS
The OS was defined as the time from the start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) until death due to any cause. The OS was calculated using the Kaplan-Meier technique.
From baseline (Day 1) until death from any cause. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts
Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736
Blood samples were collected to determine the serum concentration of MEDI4736.
Pre-dose and within 10 minutes of end of infusion on Days 1, 85 and 113; Pre-dose on Days 29, 57 and 169; and 90 days post last dose of MEDI4736. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Initial and Second Stage Cohorts: Serum Concentrations of Olaparib
Blood samples were collected to determine the serum concentration of olaparib.
Pre-dose and 0.5-1 hour postdose on Days 1 and 22 of monotherapy; Pre-dose and 0.5-1, 1-3, 3-6 and 6-12 hours postdose on Day 15 of combination therapy. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Second Stage Cohort: Serum Concentrations of Bevacizumab
Blood samples were collected to determine the serum concentration of bevacizumab.
Pre-dose and within 10 minutes of end of infusion on Days 1 and 85; Pre-dose on Days 29 and 169; and 90 days post last dose of bevacizumab. Assessed until DCO 17 Sep 2021
Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736
Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for MEDI4736 using validated assays. ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was defined as the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Treatment-boosted ADA was defined as baseline ADA titer that was boosted to 4-fold or higher following drug administration. Persistently positive was defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.
Pre-dose on Days 1, 15, 57, 85, 113 and 169; and 90 days post-last dose of MEDI4736. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
Towson
Maryland
21204
United States
Research Site
Boston
Massachusetts
02114
United States
Research Site
Detroit
Michigan
48202
United States
Research Site
St Louis
Missouri
63110
United States
Research Site
Hilliard
Ohio
43026
United States
Research Site
Philadelphia
Pennsylvania
19104
United States
Research Site
Bordeaux
33076
France
Research Site
Caen
14076
France
Research Site
Clermont-Ferrand
63011
France
Research Site
Dijon
21079
France
Research Site
Marseille
13385
France
Research Site
Nantes
44202
France
Research Site
Paris
75014
France
Research Site
Pierre Benit Cedex
69495
France
Research Site
Toulouse
31059
France
Research Site
Villejuif
94805
France
Research Site
Haifa
91096
Israel
Research Site
Jerusalem
91031
Israel
Research Site
Petah Tikva
49100
Israel
Research Site
Ramat Gan
5265601
Israel
Research Site
Tel Aviv
6423906
Israel
Research Site
Amsterdam
1066 CX
Netherlands
Research Site
Amsterdam
1081 HV
Netherlands
Research Site
Maastricht
6229 HX
Netherlands
Research Site
Nijmegen
6525 GA
Netherlands
Research Site
Rotterdam
3075 EA
Netherlands
Research Site
Utrecht
3584 CX
Netherlands
Research Site
Goyang-si
10408
South Korea
Research Site
Seongnam-si
13620
South Korea
Research Site
Seoul
03080
South Korea
Research Site
Seoul
03722
South Korea
Research Site
Seoul
05505
South Korea
Research Site
Seoul
06273
South Korea
Research Site
Seoul
06591
South Korea
Research Site
Seoul
135-710
South Korea
Research Site
Chur
CH-7000
Switzerland
Research Site
Lausanne
1011
Switzerland
Research Site
Cambridge
CB2 0QQ
United Kingdom
Research Site
Dundee
DD1 9SY
United Kingdom
Research Site
Glasgow
G12 0YN
United Kingdom
Research Site
Greater London
SW3 6JJ
United Kingdom
Research Site
London
NW1 2PG
United Kingdom
Research Site
London
SE1 9RY
United Kingdom
Research Site
Manchester
M20 4BX
United Kingdom
Research Site
Newcastle upon Tyne
NE7 7DN
United Kingdom
Research Site
Sutton
SM2 5PT
United Kingdom
Derived
Staniszewska AD, Armenia J, King M, Michaloglou C, Reddy A, Singh M, San Martin M, Prickett L, Wilson Z, Proia T, Russell D, Thomas M, Delpuech O, O'Connor MJ, Leo E, Angell H, Valge-Archer V. PARP inhibition is a modulator of anti-tumor immune response in BRCA-deficient tumors. Oncoimmunology. 2022 Jun 18;11(1):2083755. doi: 10.1080/2162402X.2022.2083755. eCollection 2022.
Domchek SM, Postel-Vinay S, Im SA, Park YH, Delord JP, Italiano A, Alexandre J, You B, Bastian S, Krebs MG, Wang D, Waqar SN, Lanasa M, Rhee J, Gao H, Rocher-Ros V, Jones EV, Gulati S, Coenen-Stass A, Kozarewa I, Lai Z, Angell HK, Opincar L, Herbolsheimer P, Kaufman B. Olaparib and durvalumab in patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA): an open-label, multicentre, phase 1/2, basket study. Lancet Oncol. 2020 Sep;21(9):1155-1164. doi: 10.1016/S1470-2045(20)30324-7. Epub 2020 Aug 6.
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
FG002
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
FG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
FG004
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
FG005
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kilogram (kg) IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
FG006
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
FG00040 subjects
FG00134 subjects
FG00234 subjects
FG00340 subjects
FG00451 subjects
FG00531 subjects
FG00632 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00040 subjects
FG00134 subjects
FG00234 subjects
FG00340 subjects
FG00451 subjects
FG00531 subjects
FG00632 subjects
Type
Comment
Reasons
Death
FG00036 subjects
FG00124 subjects
FG00226 subjects
FG00335 subjects
FG00413 subjects
FG00517 subjects
FG00620 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0018 subjects
FG0027 subjects
FG0034 subjects
FG004
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
BG001
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
BG002
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
BG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
BG004
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
BG005
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
BG006
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00038
BG00130
BG00232
BG00339
BG00451
BG00531
BG00632
BG007253
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00017
BG00129
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00021
BG00117
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
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
Primary
Initial Stage Cohorts: Disease Control Rate (DCR) at Week 12
The DCR at 12 weeks was defined as the percentage of participants who had complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks. Participants demonstrated SD for a minimum interval of 11 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 77 days) following the start of treatment. The DCR was determined using Investigator assessments according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).
Posted
Number
percentage of participants
RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.
ID
Title
Description
OG000
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG001
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG002
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG00038
OG00130
OG00232
OG003
Title
Denominators
Categories
Title
Measurements
OG00028.9
OG00180.0
OG00281.3
OG003
Primary
Second Stage Cohort: Objective Response Rate (ORR)
The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% confidence interval (CI) were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion.
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).
Posted
Number
95% Confidence Interval
percentage of participants
RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
ID
Title
Description
OG000
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG000
Primary
Second Stage Cohorts: DCR at Week 24
The DCR at 24 weeks was defined as the percentage of participants who had CR + PR + SD at 24 weeks. Participants demonstrated SD for a minimum interval of 23 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).
Posted
Number
percentage of participants
RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
ID
Title
Description
OG000
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG001
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Secondary
Second Stage Expansion Cohort: DCR at Week 24
The DCR at 24 weeks was defined as the percentage of participants who had CR + PR + SD at 24 weeks. Participants demonstrated SD for a minimum interval of 23 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 161 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).
Posted
Number
percentage of participants
RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
ID
Title
Description
OG000
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG000
Secondary
Initial Stage Cohorts: DCR at Week 28
The DCR at 28 weeks was defined as the percentage of participants who had CR + PR + SD at 28 weeks. Participants demonstrated SD for a minimum interval of 27 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 189 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).
Posted
Number
percentage of participants
RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019.
ID
Title
Description
OG000
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG001
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Secondary
Second Stage Cohorts: DCR at Week 56
The DCR at 56 weeks was defined as the percentage of participants who had CR + PR + SD at 56 weeks. Participants demonstrated SD for a minimum interval of 55 weeks (minus 1 week to allow for an early assessment within the assessment window, i.e. 385 days) following the start of treatment. The DCR was determined using Investigator assessments according to RECIST v1.1.
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).
Posted
Number
percentage of participants
RECIST performed at baseline, and every 8 weeks +/-7 days thereafter. Assessed until 17 Sep 2021.
ID
Title
Description
OG000
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG001
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Secondary
Initial and Second Stage Cohorts: ORR
The ORR (based on RECIST 1.1 as assessed by the Investigator) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD or last evaluable assessment in the absence of progression. The 95% CI were calculated using Exact Clopper-Pearson confidence limits for the binomial proportion.
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).
Posted
Number
95% Confidence Interval
percentage of participants
RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
ID
Title
Description
OG000
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG001
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Secondary
Initial and Second Stage Cohorts: Duration of Response (DoR)
The DoR (based on RECIST 1.1 as assessed by the Investigator) was defined as the time from the date of first documented response until date of documented progression or death in the absence of PD. The DoR was calculated using Kaplan-Meier technique.
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria). Only participants with objective response were analyzed.
Posted
Median
Inter-Quartile Range
months
RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
ID
Title
Description
OG000
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG001
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Secondary
Initial and Second Stage Cohorts: Progression-Free Survival (PFS)
The PFS (based on RECIST 1.1 as assessed by the Investigator) was defined as the time from start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) until the date of objective PD or death (by any cause in the absence of disease progression) regardless of whether the patient withdraws from therapy or receives another anticancer therapy prior to disease progression. The PFS was calculated using Kaplan-Meier technique.
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).
Posted
Median
95% Confidence Interval
months
RECIST performed at baseline, at 4 weeks after first dose of olaparib monotherapy (for initial stage cohort only) and every 8 weeks +/-7 days thereafter. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
ID
Title
Description
OG000
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG001
Initial Stage: Breast Cancer
Secondary
Initial Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 12 and 28
The percentage change in target tumor size at each timepoint (based on RECIST 1.1 target lesion measurements) was obtained for each participant taking the difference between the sum of the target lesions at each timepoint and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline times 100. Baseline was defined as the last evaluable assessment prior to starting olaparib treatment.
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria). Only participants with either a tumor size recorded at 12 and 28 weeks or enough information to impute a value were analyzed.
Posted
Mean
Standard Deviation
percentage change in tumor size
Baseline (Day 1) and Weeks 12 and 28. Assessed until DCO 14 Jun 2019
ID
Title
Description
OG000
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG001
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Secondary
Second Stage Cohorts: Percentage Change From Baseline in Target Tumor Size at Weeks 24 and 56
The percentage change in target tumor size at each timepoint (based on RECIST 1.1 target lesion measurements) was obtained for each participant taking the difference between the sum of the target lesions at each timepoint and the sum of the target lesions at baseline divided by the sum of the target lesions at baseline times 100. Baseline was defined as the last assessment prior to Cycle 1 Day 1.
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria). Only participants with either a tumor size recorded at 24 and 56 weeks or enough information to impute a value were analyzed.
Posted
Mean
Standard Deviation
percentage change in tumor size
Baseline (Day 1) and Weeks 24 and 56. Assessed until DCO 17 Sep 2021
ID
Title
Description
OG000
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG001
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Secondary
Initial and Second Stage Cohorts: Best Percentage Change From Baseline in Target Tumor Size
The best percentage change from baseline in target tumor size was based on RECIST 1.1 target lesion measurements taken at each RECIST 1.1 assessment. All measurements until PD or the last evaluable assessment in the absence of PD was included in the calculation. Baseline was defined as the last evaluable assessment prior to starting olaparib treatment for initial stage cohorts. Baseline was defined as the last assessment prior to Cycle 1 Day 1 for second stage cohorts.
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria). Only participants with at least 1 post baseline RECIST target lesion assessment scan were analyzed.
Posted
Mean
Standard Deviation
percentage change in tumor size
From baseline (Day 1) until confirmed PD/death. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
ID
Title
Description
OG000
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG001
Initial Stage: Breast Cancer
Secondary
Initial and Second Stage Cohorts: Time to Study Treatment Discontinuation or Death (TDT)
The TDT was defined as the time from start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) to the earlier of the date of study treatment discontinuation or death. The TDT was calculated using the Kaplan-Meier technique.
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).
Posted
Median
95% Confidence Interval
months
From baseline (Day 1) until treatment discontinuation/death. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
ID
Title
Description
OG000
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG001
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Secondary
Initial and Second Stage Cohorts: OS
The OS was defined as the time from the start of study treatment (Day 1; start of olaparib monotherapy for initial stage cohorts) until death due to any cause. The OS was calculated using the Kaplan-Meier technique.
The full analysis set included all participants who received at least 1 dose of study treatment and had no important protocol deviation resulting in exclusion from the analysis set as defined in the Statistical Analysis Plan (i.e, not meeting key eligibility criteria).
Posted
Median
95% Confidence Interval
months
From baseline (Day 1) until death from any cause. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts
ID
Title
Description
OG000
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG001
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Secondary
Initial and Second Stage Cohorts: Serum Concentrations of MEDI4736
Blood samples were collected to determine the serum concentration of MEDI4736.
The MEDI4736 pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of MEDI4736 and provided evaluable MEDI4736 PK profile for at least 1 treatment period.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram per milliliter (mcg/mL)
Pre-dose and within 10 minutes of end of infusion on Days 1, 85 and 113; Pre-dose on Days 29, 57 and 169; and 90 days post last dose of MEDI4736. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
ID
Title
Description
OG000
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG001
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Secondary
Initial and Second Stage Cohorts: Serum Concentrations of Olaparib
Blood samples were collected to determine the serum concentration of olaparib.
The olaparib PK analysis set included all participants who received at least 1 dose of olaparib and provided evaluable olaparib PK profile for at least 1 treatment period.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg/mL
Pre-dose and 0.5-1 hour postdose on Days 1 and 22 of monotherapy; Pre-dose and 0.5-1, 1-3, 3-6 and 6-12 hours postdose on Day 15 of combination therapy. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
ID
Title
Description
OG000
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG001
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG002
Secondary
Second Stage Cohort: Serum Concentrations of Bevacizumab
Blood samples were collected to determine the serum concentration of bevacizumab.
The bevacizumab PK analysis set included all participants who received at least 1 dose of bevacizumab and provided any post-dose evaluable bevacizumab PK concentration.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg/mL
Pre-dose and within 10 minutes of end of infusion on Days 1 and 85; Pre-dose on Days 29 and 169; and 90 days post last dose of bevacizumab. Assessed until DCO 17 Sep 2021
ID
Title
Description
OG000
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG000
Secondary
Initial and Second Stage Cohorts: Number of Participants With Anti-Drug Antibody (ADA) Response to MEDI4736
Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for MEDI4736 using validated assays. ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was defined as the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA. Treatment-boosted ADA was defined as baseline ADA titer that was boosted to 4-fold or higher following drug administration. Persistently positive was defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive.
The ADA analysis set included all participants in the safety analysis set who have non-missing baseline ADA and at least 1 non-missing post-baseline ADA result for MEDI4736.
Posted
Count of Participants
Participants
Pre-dose on Days 1, 15, 57, 85, 113 and 169; and 90 days post-last dose of MEDI4736. Assessed until DCO 14 Jun 2019 and 17 Sep 2021 for initial and second stage cohorts, respectively
ID
Title
Description
OG000
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Time Frame
Treatment-emergent adverse events were reported from the first dose administration up to 90 days following the date of last dose of study treatment. Assessed until DCO 14 Jun 2019 for initial stage cohorts except for ovarian cancer cohort and DCO 17 Sep 2021 for initial stage ovarian cancer cohort and second stage cohorts.
Description
The safety analysis set included all participants who received at least 1 dose of study treatment.
For initial stage cohorts except ovarian cancer cohort: MedDRA 22.0. For initial stage ovarian cancer and second stage cohorts: MedDRA 24.0.
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
Initial Stage: Small Cell Lung Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
36
40
23
40
40
40
EG001
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
24
34
4
34
34
34
EG002
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
26
34
10
34
32
34
EG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
35
40
10
40
40
40
EG004
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
13
51
13
51
50
51
EG005
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
17
31
6
31
31
31
EG006
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
20
32
8
32
32
32
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cholangitis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG0031 events1 affected40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
Asthenia
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Fatigue
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Device related infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0025 events1 affected34 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected34 at risk
EG0022 events1 affected34 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Hepatic cytolysis
Hepatobiliary disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Osteoporotic fracture
Musculoskeletal and connective tissue disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Encephalitis autoimmune
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0003 events3 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Febrile bone marrow aplasia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
General physical health deterioration
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Malaise
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pyrexia
General disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected34 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Device related infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0025 events1 affected34 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Lower respiratory tract infection viral
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected34 at risk
EG0022 events1 affected34 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Sepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Septic shock
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Streptococcal infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 24.0
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Blood testosterone decreased
Investigations
MedDRA 24.0
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected34 at risk
EG003
Acute myeloid leukaemia
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
D001941
Breast Diseases
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D002283
Carcinoma, Bronchogenic
D001984
Bronchial Neoplasms
D008175
Lung Neoplasms
D012142
Respiratory Tract Neoplasms
D013899
Thoracic Neoplasms
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C531550
olaparib
C000613593
durvalumab
D000068258
Bevacizumab
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
1 subjects
FG0050 subjects
FG0060 subjects
3 subjects
FG0050 subjects
FG0062 subjects
34 subjects
FG00514 subjects
FG00610 subjects
0
BG0040
BG0050
BG0060
BG0070
Between 18 and 65 years
BG00023
BG00129
BG00227
BG00329
BG00438
BG00517
BG00612
BG007175
>=65 years
BG00015
BG0011
BG0025
BG00310
BG00413
BG00514
BG00620
BG00778
32
BG00313
BG00451
BG00531
BG00632
BG007205
Male
BG00021
BG0011
BG0020
BG00326
BG0040
BG0050
BG0060
BG00748
22
BG00324
BG00434
BG00520
BG00624
BG007162
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0071
Asian
BG0006
BG0017
BG0026
BG00313
BG00412
BG00510
BG0063
BG00757
Other
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0071
Missing
BG00011
BG0016
BG0024
BG0032
BG0044
BG0050
BG0065
BG00732
0
BG0030
BG0040
BG0051
BG0060
BG0071
Not Hispanic or Latino
BG00027
BG00124
BG00228
BG00337
BG00447
BG00530
BG00627
BG007220
Missing
BG00011
BG0016
BG0024
BG0032
BG0044
BG0050
BG0065
BG00732
39
25.6
51
Title
Denominators
Categories
Title
Measurements
OG00092.2(81.12 to 97.82)
Units
Counts
Participants
OG00031
OG00132
Title
Denominators
Categories
Title
Measurements
OG00074.2
OG00128.1
51
Title
Denominators
Categories
Title
Measurements
OG00088.2
OG002
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG00038
OG00130
OG00232
OG00339
Title
Denominators
Categories
Title
Measurements
OG0005.3
OG00150.0
OG00265.6
OG0037.7
OG002
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG00051
OG00131
OG00232
Title
Denominators
Categories
Title
Measurements
OG00041.2
OG00138.7
OG0029.4
OG002
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG004
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG005
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG00038
OG00130
OG00232
OG00339
OG00431
OG00532
Title
Denominators
Categories
Title
Measurements
OG00010.5(2.94 to 24.80)
OG00163.3(43.86 to 80.07)
OG00271.9(53.25 to 86.25)
OG00310.3(2.87 to 24.22)
OG00487.1(70.17 to 96.37)
OG00534.4(18.57 to 53.19)
OG002
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG004
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG005
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG006
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG0004
OG00119
OG00223
OG0034
OG00447
OG00527
OG00611
Title
Denominators
Categories
Title
Measurements
OG0003.6(2.6 to 4.6)
OG0019.2(5.5 to 20.3)
OG00210.2(5.7 to 22.3)
OG00314.8(6.4 to NA)Upper limit of Inter-quartile range was not reached.
OG00414.8(9.0 to NA)Upper limit of Inter-quartile range was not reached.
OG00511.1(7.4 to 22.1)
OG0066.9(5.4 to 11.1)
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG002
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG004
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG005
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG006
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG00038
OG00130
OG00232
OG00339
OG00451
OG00531
OG00632
Title
Denominators
Categories
Title
Measurements
OG0002.4(0.9 to 3.0)
OG0018.2(4.6 to 11.8)
OG00212.0(8.2 to 15.9)
OG0032.6(1.4 to 2.8)
OG00415.0(12.9 to 24.1)
OG00514.7(9.2 to 18.1)
OG0065.5(3.6 to 7.5)
OG002
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG00022
OG00129
OG00229
OG00321
Title
Denominators
Categories
Week 12
ParticipantsOG00022
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG00321
Title
Measurements
OG00017.23± 54.752
OG001-26.13± 43.033
OG002-35.86± 29.791
OG003
Week 28
ParticipantsOG0005
ParticipantsOG00119
ParticipantsOG00226
ParticipantsOG0034
OG002
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG00047
OG00127
OG00215
Title
Denominators
Categories
Week 24
ParticipantsOG00047
ParticipantsOG00127
ParticipantsOG00215
Title
Measurements
OG000-66.30± 26.672
OG001-43.00± 32.432
OG002-35.63± 34.001
Week 56
ParticipantsOG00026
ParticipantsOG00115
ParticipantsOG0025
Title
Measurements
OG000
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG002
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG004
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG005
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG006
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG00036
OG00130
OG00231
OG00337
OG00451
OG00531
OG00632
Title
Denominators
Categories
Title
Measurements
OG0006.27± 32.398
OG001-47.60± 36.823
OG002-55.55± 35.789
OG0031.64± 42.338
OG004-72.78± 31.497
OG005-53.30± 33.317
OG006-20.42± 41.160
OG002
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG004
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG005
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG006
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG00038
OG00130
OG00232
OG00339
OG00451
OG00531
OG00632
Title
Denominators
Categories
Title
Measurements
OG0002.8(2.0 to 3.8)
OG0017.8(6.2 to 12.1)
OG00213.1(8.2 to 15.9)
OG0032.8(2.1 to 3.2)
OG00419.3(14.7 to 26.2)
OG00515.9(10.3 to 18.4)
OG0066.6(4.4 to 8.5)
OG002
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG004
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG005
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG006
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG00038
OG00130
OG00232
OG00339
OG00451
OG00531
OG00632
Title
Denominators
Categories
Title
Measurements
OG0007.6(5.6 to 8.8)
OG00120.5(16.2 to 25.5)
OG00235.5(27.2 to 50.7)
OG0036.4(4.3 to 9.1)
OG004NA(NA to NA)Median and 95% CI had not reached.
OG00531.9(22.1 to NA)Upper limit of 95% CI had not reached.
OG00626.1(18.7 to NA)Upper limit of 95% CI had not reached.
OG002
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG004
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG005
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG006
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG00036
OG00134
OG00232
OG00336
OG00451
OG00531
OG00632
Title
Denominators
Categories
Day 1: Pre-dose
ParticipantsOG00036
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00336
ParticipantsOG00442
ParticipantsOG00530
ParticipantsOG00631
Title
Measurements
OG000NA± NANA = Below the lower limit of quantification (LLOQ). The LLOQ of MEDI4736 is 0.05 mcg/mL.
OG001NA± NANA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.
OG002NA± NANA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.
OG003
Day 1: End of infusion
ParticipantsOG00036
ParticipantsOG00132
ParticipantsOG00231
ParticipantsOG00335
Day 29: Pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 57: Pre-dose
ParticipantsOG00017
ParticipantsOG00128
ParticipantsOG00229
ParticipantsOG00314
Day 85: Pre-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 85: End of infusion
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 113: Pre-dose
ParticipantsOG0005
ParticipantsOG00125
ParticipantsOG00224
ParticipantsOG0036
Day 113: End of infusion
ParticipantsOG0005
ParticipantsOG00125
ParticipantsOG00223
ParticipantsOG0036
Day 169: Pre-dose
ParticipantsOG0003
ParticipantsOG00120
ParticipantsOG00223
ParticipantsOG0034
90 days post last dose
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG0028
ParticipantsOG0036
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG004
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG005
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG006
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG00040
OG00133
OG00233
OG00324
OG00439
OG00527
OG00627
Title
Denominators
Categories
Monotherapy - Day 1: Pre-dose
ParticipantsOG00040
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00324
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000NA± NANA = Below LLOQ. The LLOQ of olaparib is 0.0005 mcg/mL.
OG001NA± NANA = Below LLOQ. The LLOQ of olaparib is 0.0005 mcg/mL.
OG002NA± NANA = Below LLOQ. The LLOQ of olaparib is 0.0005 mcg/mL.
OG003
Monotherapy - Day 1: 0.5-1 hour postdose
ParticipantsOG00039
ParticipantsOG00130
ParticipantsOG00233
ParticipantsOG00323
Monotherapy - Day 22: Pre-dose
ParticipantsOG00028
ParticipantsOG00128
ParticipantsOG00225
ParticipantsOG00316
Monotherapy - Day 22: 0.5-1 hour postdose
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00226
ParticipantsOG00317
Combination therapy - Day 15: Pre-dose
ParticipantsOG00029
ParticipantsOG00132
ParticipantsOG00226
ParticipantsOG00317
Combination therapy - Day 15: 0.5-1 hour postdose
ParticipantsOG00026
ParticipantsOG00131
ParticipantsOG00226
ParticipantsOG003
Combination therapy - Day 15: 1-3 hour postdose
ParticipantsOG00025
ParticipantsOG00130
ParticipantsOG00227
ParticipantsOG003
Combination therapy - Day 15: 3-6 hour postdose
ParticipantsOG00025
ParticipantsOG00130
ParticipantsOG00226
ParticipantsOG003
Combination therapy - Day 15: 6-12 hour postdose
ParticipantsOG00024
ParticipantsOG00130
ParticipantsOG00226
ParticipantsOG003
31
Title
Denominators
Categories
Day 1: Pre-dose
ParticipantsOG00025
Title
Measurements
OG000NA± NANA = Below LLOQ. The LLOQ of bevacizumab is 0.5 mcg/mL.
Day 1: End of infusion
ParticipantsOG00028
Title
Measurements
OG000243.7± 30.01
Day 29: Pre-dose
ParticipantsOG00031
Title
Measurements
OG000104.6± 29.30
Day 85: Pre-dose
ParticipantsOG00026
Title
Measurements
OG000145.5± 28.26
Day 85: End of infusion
ParticipantsOG00021
Title
Measurements
OG000364.0± 23.74
Day 169: Pre-dose
ParticipantsOG00025
Title
Measurements
OG000147.9± 118.0
90 days post last dose
ParticipantsOG00010
Title
Measurements
OG0005.094± 224.1
OG001
Initial Stage: Breast Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG002
Initial Stage: Ovarian Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG003
Initial Stage: Gastric Cancer
Participants received monotherapy with olaparib 300 mg orally twice daily for 4 weeks. Participants then continued to receive combination therapy with olaparib and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG004
Second Stage: Ovarian Cancer Expansion
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG005
Second Stage: Ovarian Cancer Triplet
Participants received combination therapy with olaparib 300 mg orally twice daily plus MEDI4736 1.5 g IV infusion every 4 weeks plus bevacizumab 10 mg/kg IV infusion every 2 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
OG006
Second Stage: Ovarian Cancer Doublet
Participants received combination therapy with olaparib 300 mg orally twice daily and MEDI4736 1.5 g IV infusion every 4 weeks in 28-day cycle until PD or specific treatment discontinuation criteria were met.
Units
Counts
Participants
OG00033
OG00132
OG00231
OG00335
OG0040
OG00529
OG00625
Title
Denominators
Categories
ADA prevalence
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0050
OG0060
ADA incidence
Title
Measurements
OG0000
OG0010
OG0020
OG003
ADA positive post-baseline and positive at baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
ADA positive post-baseline and not detected at baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
ADA not detected post-baseline and positive at baseline
Title
Measurements
OG0000
OG0010
OG0020
OG003
Treatment-boosted ADA
Title
Measurements
OG0000
OG0010
OG0020
OG003
Persistent positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
Transient positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any nAb positive among any ADA positive
Title
Measurements
OG0000
OG0010
OG0020
OG003
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
18 events
15 affected
40 at risk
EG00439 events25 affected51 at risk
EG00541 events18 affected31 at risk
EG00620 events13 affected32 at risk
1 events
1 affected
40 at risk
EG0042 events2 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0042 events2 affected51 at risk
EG0058 events4 affected31 at risk
EG0060 events0 affected32 at risk
4 events
3 affected
40 at risk
EG0041 events1 affected51 at risk
EG0052 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected51 at risk
EG0053 events3 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0043 events2 affected51 at risk
EG0052 events2 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG00414 events8 affected51 at risk
EG00512 events9 affected31 at risk
EG0066 events5 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0045 events5 affected51 at risk
EG00510 events5 affected31 at risk
EG0063 events3 affected32 at risk
2 events
2 affected
40 at risk
EG0044 events3 affected51 at risk
EG0050 events0 affected31 at risk
EG0063 events3 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
5 events
5 affected
40 at risk
EG0041 events1 affected51 at risk
EG0054 events3 affected31 at risk
EG0062 events2 affected32 at risk
1 events
1 affected
40 at risk
EG0045 events3 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0054 events4 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG00411 events10 affected51 at risk
EG0052 events2 affected31 at risk
EG0065 events5 affected32 at risk
1 events
1 affected
40 at risk
EG0043 events3 affected51 at risk
EG0051 events1 affected31 at risk
EG0064 events4 affected32 at risk
22 events
16 affected
40 at risk
EG00423 events21 affected51 at risk
EG0058 events8 affected31 at risk
EG0069 events8 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0043 events3 affected51 at risk
EG0055 events4 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected51 at risk
EG0051 events1 affected31 at risk
EG0062 events2 affected32 at risk
24 events
20 affected
40 at risk
EG00451 events34 affected51 at risk
EG00544 events23 affected31 at risk
EG00646 events28 affected32 at risk
2 events
2 affected
40 at risk
EG0048 events8 affected51 at risk
EG0058 events7 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0054 events4 affected31 at risk
EG0060 events0 affected32 at risk
28 events
17 affected
40 at risk
EG00437 events20 affected51 at risk
EG00527 events16 affected31 at risk
EG0066 events4 affected32 at risk
5 events
5 affected
40 at risk
EG0046 events6 affected51 at risk
EG0052 events1 affected31 at risk
EG0068 events7 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
11 events
11 affected
40 at risk
EG00436 events28 affected51 at risk
EG00525 events16 affected31 at risk
EG00622 events16 affected32 at risk
2 events
2 affected
40 at risk
EG0044 events4 affected51 at risk
EG0058 events3 affected31 at risk
EG0065 events4 affected32 at risk
1 events
1 affected
40 at risk
EG0044 events3 affected51 at risk
EG0050 events0 affected31 at risk
EG0063 events2 affected32 at risk
0 events
0 affected
40 at risk
EG0043 events3 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
5 events
5 affected
40 at risk
EG0041 events1 affected51 at risk
EG0053 events3 affected31 at risk
EG0065 events4 affected32 at risk
3 events
3 affected
40 at risk
EG0041 events1 affected51 at risk
EG0051 events1 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0046 events3 affected51 at risk
EG0052 events2 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0053 events2 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
1 events
1 affected
40 at risk
EG0044 events3 affected51 at risk
EG0054 events2 affected31 at risk
EG0062 events2 affected32 at risk
1 events
1 affected
40 at risk
EG0042 events1 affected51 at risk
EG0056 events2 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0045 events3 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0055 events3 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0046 events6 affected51 at risk
EG0052 events2 affected31 at risk
EG0063 events3 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0051 events1 affected31 at risk
EG0063 events2 affected32 at risk
1 events
1 affected
40 at risk
EG0044 events4 affected51 at risk
EG0051 events1 affected31 at risk
EG0067 events3 affected32 at risk
3 events
3 affected
40 at risk
EG0042 events2 affected51 at risk
EG0052 events2 affected31 at risk
EG0063 events3 affected32 at risk
1 events
1 affected
40 at risk
EG00415 events8 affected51 at risk
EG00512 events7 affected31 at risk
EG0062 events2 affected32 at risk
1 events
1 affected
40 at risk
EG00410 events6 affected51 at risk
EG00511 events5 affected31 at risk
EG00611 events7 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0053 events2 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected51 at risk
EG0054 events3 affected31 at risk
EG0063 events2 affected32 at risk
2 events
2 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected51 at risk
EG0055 events3 affected31 at risk
EG0062 events2 affected32 at risk
0 events
0 affected
40 at risk
EG0043 events3 affected51 at risk
EG0054 events3 affected31 at risk
EG0064 events4 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0057 events4 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0062 events2 affected32 at risk
16 events
14 affected
40 at risk
EG00414 events12 affected51 at risk
EG0058 events7 affected31 at risk
EG0063 events3 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0052 events2 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0049 events4 affected51 at risk
EG0056 events4 affected31 at risk
EG0063 events2 affected32 at risk
15 events
15 affected
40 at risk
EG00412 events10 affected51 at risk
EG00519 events12 affected31 at risk
EG00613 events9 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0053 events2 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0052 events1 affected31 at risk
EG0061 events1 affected32 at risk
1 events
1 affected
40 at risk
EG0042 events2 affected51 at risk
EG0051 events1 affected31 at risk
EG0063 events3 affected32 at risk
3 events
3 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0061 events1 affected32 at risk
2 events
2 affected
40 at risk
EG0048 events6 affected51 at risk
EG00511 events9 affected31 at risk
EG00611 events8 affected32 at risk
2 events
2 affected
40 at risk
EG0048 events8 affected51 at risk
EG0055 events5 affected31 at risk
EG0067 events7 affected32 at risk
3 events
3 affected
40 at risk
EG0046 events5 affected51 at risk
EG0052 events1 affected31 at risk
EG0061 events1 affected32 at risk
2 events
2 affected
40 at risk
EG0046 events5 affected51 at risk
EG0054 events3 affected31 at risk
EG0061 events1 affected32 at risk
3 events
3 affected
40 at risk
EG0040 events0 affected51 at risk
EG0052 events2 affected31 at risk
EG0062 events2 affected32 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
5 events
4 affected
40 at risk
EG0044 events4 affected51 at risk
EG0055 events5 affected31 at risk
EG0068 events7 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
2 events
2 affected
40 at risk
EG0046 events6 affected51 at risk
EG0054 events3 affected31 at risk
EG0065 events4 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0061 events1 affected32 at risk
6 events
6 affected
40 at risk
EG00412 events9 affected51 at risk
EG0053 events3 affected31 at risk
EG0063 events3 affected32 at risk
0 events
0 affected
40 at risk
EG0047 events7 affected51 at risk
EG0055 events4 affected31 at risk
EG0067 events6 affected32 at risk
4 events
4 affected
40 at risk
EG00411 events8 affected51 at risk
EG00522 events11 affected31 at risk
EG0069 events7 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0053 events2 affected31 at risk
EG0060 events0 affected32 at risk
5 events
3 affected
40 at risk
EG0042 events2 affected51 at risk
EG0053 events3 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0052 events2 affected31 at risk
EG0061 events1 affected32 at risk
1 events
1 affected
40 at risk
EG0042 events2 affected51 at risk
EG0052 events2 affected31 at risk
EG0061 events1 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0053 events2 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0045 events4 affected51 at risk
EG0053 events3 affected31 at risk
EG0062 events2 affected32 at risk
1 events
1 affected
40 at risk
EG0042 events2 affected51 at risk
EG0054 events1 affected31 at risk
EG0061 events1 affected32 at risk
1 events
1 affected
40 at risk
EG0044 events4 affected51 at risk
EG0053 events3 affected31 at risk
EG0063 events3 affected32 at risk
0 events
0 affected
40 at risk
EG0044 events4 affected51 at risk
EG0051 events1 affected31 at risk
EG0064 events3 affected32 at risk
2 events
2 affected
40 at risk
EG0048 events8 affected51 at risk
EG0054 events4 affected31 at risk
EG0065 events5 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0052 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0042 events2 affected51 at risk
EG0051 events1 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0043 events1 affected51 at risk
EG0052 events2 affected31 at risk
EG0061 events1 affected32 at risk
2 events
2 affected
40 at risk
EG0043 events3 affected51 at risk
EG0054 events3 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG00511 events9 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
5 events
5 affected
40 at risk
EG00415 events11 affected51 at risk
EG0055 events5 affected31 at risk
EG0064 events3 affected32 at risk
1 events
1 affected
40 at risk
EG0041 events1 affected51 at risk
EG0056 events5 affected31 at risk
EG0061 events1 affected32 at risk
2 events
2 affected
40 at risk
EG00418 events13 affected51 at risk
EG0056 events4 affected31 at risk
EG0064 events4 affected32 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0059 events7 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0052 events1 affected31 at risk
EG0060 events0 affected32 at risk
3 events
3 affected
40 at risk
EG0042 events2 affected51 at risk
EG0051 events1 affected31 at risk
EG0063 events3 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0043 events3 affected51 at risk
EG0052 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0044 events2 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
1 events
1 affected
40 at risk
EG0045 events5 affected51 at risk
EG0054 events3 affected31 at risk
EG0063 events3 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0043 events3 affected51 at risk
EG0057 events5 affected31 at risk
EG0063 events3 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0053 events2 affected31 at risk
EG0060 events0 affected32 at risk
5 events
3 affected
40 at risk
EG0048 events6 affected51 at risk
EG0054 events3 affected31 at risk
EG0065 events5 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
9 events
6 affected
40 at risk
EG00411 events7 affected51 at risk
EG00510 events7 affected31 at risk
EG0063 events3 affected32 at risk
0 events
0 affected
40 at risk
EG0046 events5 affected51 at risk
EG0050 events0 affected31 at risk
EG0062 events2 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0043 events3 affected51 at risk
EG0051 events1 affected31 at risk
EG0062 events2 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0052 events2 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0062 events2 affected32 at risk
0 events
0 affected
40 at risk
EG0041 events1 affected51 at risk
EG0050 events0 affected31 at risk
EG0061 events1 affected32 at risk
0 events
0 affected
40 at risk
EG0046 events4 affected51 at risk
EG00519 events8 affected31 at risk
EG0064 events2 affected32 at risk
2 events
2 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
2 events
2 affected
40 at risk
EG0043 events3 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
3 events
1 affected
40 at risk
EG0040 events0 affected51 at risk
EG0054 events4 affected31 at risk
EG0061 events1 affected32 at risk
9 events
8 affected
40 at risk
EG00419 events15 affected51 at risk
EG00510 events8 affected31 at risk
EG0069 events6 affected32 at risk
2 events
2 affected
40 at risk
EG0043 events3 affected51 at risk
EG0051 events1 affected31 at risk
EG0061 events1 affected32 at risk
2 events
2 affected
40 at risk
EG0042 events2 affected51 at risk
EG0051 events1 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0043 events3 affected51 at risk
EG0053 events1 affected31 at risk
EG0060 events0 affected32 at risk
16 events
11 affected
40 at risk
EG00428 events17 affected51 at risk
EG00527 events12 affected31 at risk
EG00621 events14 affected32 at risk
0 events
0 affected
40 at risk
EG0045 events5 affected51 at risk
EG0051 events1 affected31 at risk
EG0064 events3 affected32 at risk
7 events
7 affected
40 at risk
EG0045 events5 affected51 at risk
EG0056 events6 affected31 at risk
EG0064 events4 affected32 at risk
5 events
4 affected
40 at risk
EG0042 events2 affected51 at risk
EG0050 events0 affected31 at risk
EG0060 events0 affected32 at risk
0 events
0 affected
40 at risk
EG0040 events0 affected51 at risk
EG0051 events1 affected31 at risk
EG0062 events2 affected32 at risk
4 events
4 affected
40 at risk
EG0043 events3 affected51 at risk
EG0053 events2 affected31 at risk
EG0063 events3 affected32 at risk
20.81
± 75.944
Title
Measurements
OG000-2.05± 15.671
OG001-40.85± 39.541
OG002-53.74± 31.147
OG003-41.00± 43.625
-77.74
± 26.472
OG001-60.00± 29.058
OG002-39.54± 33.719
NA
± NA
NA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.
OG004NA± NANA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.
OG005NA± NANA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.
OG006NA± NANA = Below LLOQ. The LLOQ of MEDI4736 is 0.05 mcg/mL.
ParticipantsOG00446
ParticipantsOG00531
ParticipantsOG00631
Title
Measurements
OG000483.5± 35.09
OG001542.5± 36.04
OG002417.9± 33.48
OG003391.8± 25.09
OG004409.3± 33.27
OG005498.8± 30.27
OG006397.1± 18.53
Participants
OG004
43
ParticipantsOG00531
ParticipantsOG00631
Title
Measurements
OG00493.56± 54.83
OG00596.50± 34.67
OG00678.23± 56.60
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000144.7± 38.96
OG001165.2± 40.31
OG002171.3± 31.73
OG003114.7± 44.78
Participants
OG004
48
ParticipantsOG00527
ParticipantsOG00625
Title
Measurements
OG004152.8± 50.14
OG005145.2± 55.71
OG006142.8± 63.07
ParticipantsOG00444
ParticipantsOG00527
ParticipantsOG00623
Title
Measurements
OG004610.6± 39.64
OG005589.3± 35.48
OG006482.9± 44.01
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000119.5± 44.27
OG001220.7± 35.97
OG002231.3± 33.45
OG003196.9± 74.60
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
Title
Measurements
OG000504.8± 25.24
OG001671.5± 31.79
OG002585.5± 52.67
OG003679.1± 34.80
ParticipantsOG00442
ParticipantsOG00525
ParticipantsOG00615
Title
Measurements
OG000133.1± 30.74
OG001231.5± 41.14
OG002261.6± 45.92
OG003230.7± 35.81
OG004206.3± 61.24
OG005162.6± 95.86
OG006186.6± 65.36
ParticipantsOG0048
ParticipantsOG0059
ParticipantsOG0069
Title
Measurements
OG0006.907± 297.9
OG00112.24± 4720
OG00222.35± 120.9
OG00317.23± 155.2
OG00417.94± 331.8
OG00517.47± 78.93
OG00620.50± 340.0
NA
± NA
NA = Below LLOQ. The LLOQ of olaparib is 0.0005 mcg/mL.