A Study of Pembrolizumab (MK-3475) With or Without Mainte... | NCT03976362 | Trialant
NCT03976362
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Feb 25, 2026Actual
Enrollment
851Actual
Phase
Phase 3
Conditions
Carcinoma, Squamous Cell, Non-small-cell Lung
Interventions
Pembrolizumab
Carboplatin
Paclitaxel
Nab-paclitaxel
Olaparib
Placebo
Countries
United States
Argentina
Australia
Austria
Brazil
Canada
France
Germany
Japan
Mexico
New Zealand
Poland
Romania
Russia
South Korea
Spain
Taiwan
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03976362
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
7339-008
Secondary IDs
ID
Type
Description
Link
MK-7339-008
Other Identifier
MSD Protocol Number
KEYLYNK-008
Other Identifier
MSD
194894
Registry Identifier
JAPIC-CTI
2023-508449-41-00
Registry Identifier
EU CT
U1111-1298-1950
Registry Identifier
UTN
2018-004721-88
EudraCT Number
Brief Title
A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)
Official Title
A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Feb 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 28, 2019Actual
Primary Completion Date
Sep 21, 2023Actual
Completion Date
Jan 30, 2026Actual
First Submitted Date
Jun 3, 2019
First Submission Date that Met QC Criteria
Jun 3, 2019
First Posted Date
Jun 6, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Sep 18, 2024
Results First Submitted that Met QC Criteria
Nov 1, 2024
Results First Posted Date
Nov 6, 2024Actual
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
Feb 12, 2026
Last Update Posted Date
Feb 25, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are:
Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR).
Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS).
As of Amendment 07, there will be no further analyses for OS and patient-reported outcome assessments.
Detailed Description
This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles of pembrolizumab). In the Induction Phase, participants receive pembrolizumab plus carboplatin plus a taxane (paclitaxel or nab-paclitaxel). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive pembrolizumab plus maintenance olaparib OR pembrolizumab plus maintenance olaparib placebo. In the Maintenance Phase, participants randomly assigned to receive pembrolizumab for up to 31 cycles plus maintenance olaparib OR maintenance olaparib placebo until centrally verified progressive disease (PD), intolerable toxicities, or physician decision.
As of Amendment 07, participants actively taking placebo will discontinue taking the placebo intervention and continue in the study.
Conditions Module
Conditions
Carcinoma, Squamous Cell, Non-small-cell Lung
Keywords
PD-1
PD L1
PD L2
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
851Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Pembrolizumab + Carboplatin + Taxane + Olaparib
Experimental
For the Induction Phase, participants receive 4 cycles:
Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy.
For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
For the Induction Phase, participants receive 4 cycles:
Pembrolizumab 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant is randomized to maintenance therapy.
For the Maintenance Phase, participants receive pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continues to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Progression-free Survival was defined as the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, progressive disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 is presented. PFS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 39 months
Overall Survival (OS)
Overall survival was the time from the date of randomization to death due to any cause. OS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 46 months
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With One or More Adverse Events (AEs)
An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The number of participants who reported 1 or more AEs is presented. Per protocol this outcome measure was not planned for the Induction Phase.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
Have Stage IV squamous NSCLC.
Have measurable disease based on RECIST 1.1.
Have not received prior systemic treatment for their advanced/metastatic NSCLC.
Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention
Have a life expectancy of at least 3 months.
Has adequate organ function.
Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.
Exclusion Criteria:
Has non-squamous histology NSCLC.
Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
Has known active central nervous system metastases and/or carcinomatous meningitis.
Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib.
Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
Hochmair M, Schenker M, Cobo Dols M, Kim TM, Ozyilkan O, Smagina M, Leonova V, Kato T, Fedenko A, De Angelis F, Rittmeyer A, Gray JE, Greystoke A, Aggarwal H, Huang Q, Zhao B, Lara-Guerra H, Nadal E. Pembrolizumab With or Without Maintenance Olaparib for Metastatic Squamous NSCLC That Responded to First-Line Pembrolizumab Plus Chemotherapy. J Thorac Oncol. 2025 Feb;20(2):203-218. doi: 10.1016/j.jtho.2024.10.012. Epub 2024 Oct 28.
Study consisted of an Induction, Maintenance and Posttreatment phase. For induction, eligible participants were enrolled to receive pembrolizumab and carboplatin plus paclitaxel or nab-paclitaxel. Participants who met additional criteria were randomized 1:1 into a maintenance phase to receive either pembrolizumab combined with olaparib or pembrolizumab combined with placebo. In the posttreatment phase, participants were either followed up or administered a second course of pembrolizumab.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Pembrolizumab (Pembro) + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)
Participants received Pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle for 4 cycles PLUS Carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles PLUS investigator's choice of either Paclitaxel (200 mg/m^2 Q3W on Day 1 of each 21-day cycle for 4 cycles or Nab-paclitaxel (100 mg/m^2 Q3W on Days 1, 8, 15 of each 21-day cycle for 4 cycles). Participants may then randomize to one of the blinded treatment arms.
Number of Participants Who Discontinued Study Intervention Due to an AE
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The number of participants who discontinued study intervention due to an AE is presented. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 4 years
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/ Quality of Life (QoL) (Items 29 and 30) Combined Scale Score
EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the Global Health Status GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were each scored on a 7-point scale (1=Very Poor to 7=Excellent), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score was assessed using a constrained longitudinal data analysis (cLDA) model with the patient-reported outcome (PRO) score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Baseline and Week 24
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 and 30) Scale Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Item 29) and QoL score (EORTC QLQ-C30 Item 30). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10- point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 2 years
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Baseline and Week 24
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough scale score. The TTD for cough (Item 1) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 2 years
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Baseline and Week 24
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in chest pain scale score. The TTD for chest pain (Item 10) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 2 years
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score will be presented. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Baseline and Week 24
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Item 8 scale score. The TTD for dyspnea (Item 8) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 2 years
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score is presented. Change from baseline score was assessed using a constrained longitudinal data analysis (cLDA) model with the patient-reported outcome (PRO) score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
Baseline and Week 24
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores. The TTD for physical functioning (Item 1-5) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
Up to approximately 2 years
Burbank
California
91505
United States
Boca Raton Regional Hospital ( Site 0018)
Boca Raton
Florida
33486
United States
Mid-Florida Cancer Centers ( Site 0022)
Orange City
Florida
32763
United States
H. Lee Moffitt Cancer Center and Research Institute ( Site 0024)
Tampa
Florida
33612
United States
Columbus Regional Research Institute ( Site 0099)
Columbus
Georgia
31904
United States
Mount Sinai Hospital Medical Center ( Site 0035)
Chicago
Illinois
60608
United States
Oncology of Northshore ( Site 0036)
Rolling Meadows
Illinois
60008
United States
Methodists Hospitals/Premier Oncology Hematology Associates ( Site 0039)
Merrillville
Indiana
46410
United States
MedStar Franklin Square Medical Center ( Site 0044)
Baltimore
Maryland
21237
United States
Barbara Ann Karmanos Cancer Institute ( Site 0046)
Detroit
Michigan
48201
United States
Hattiesburg Clinic ( Site 0051)
Hattiesburg
Mississippi
39401
United States
Frontier Oncology ( Site 0052)
Billings
Montana
59102
United States
Bozeman Health Deaconness Cancer Center ( Site 0053)
Bozeman
Montana
59715
United States
Waverly Hematology Oncology ( Site 0054)
Cary
North Carolina
27518
United States
Thompson Cancer Survival Center ( Site 2812)
Knoxville
Tennessee
37804
United States
Renovatio Clinical ( Site 0074)
The Woodlands
Texas
77380
United States
Cancer Care Northwest ( Site 0083)
Spokane Valley
Washington
99216
United States
Hospital Italiano Regional del Sur ( Site 0509)
BahÃa Blanca
Buenos Aires
B8001HXM
Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0516)
Mar del Plata
Buenos Aires
B7600FZO
Argentina
Hospital Britanico de Buenos Aires ( Site 0500)
Buenos Aires
Buenos Aires F.D.
C1280AEB
Argentina
Instituto Medico Rio Cuarto ( Site 0501)
RÃo Cuarto
Córdoba Province
X5800AEV
Argentina
Sanatorio Parque ( Site 0515)
Rosario
Santa Fe Province
S2000DSV
Argentina
Centro Oncológico de Rosario ( Site 0507)
Rosario
Santa Fe Province
S2000KZE
Argentina
Centro Medico San Roque ( Site 0506)
San Miguel de Tucumán
Tucumán Province
T4000IAK
Argentina
Hospital Italiano de Buenos Aires ( Site 0511)
Buenos Aires
C1199ABB
Argentina
ClÃnica Universitaria Reina Fabiola ( Site 0505)
Córdoba
X5004FHP
Argentina
Sanatorio Privado San Geronimo S.R.L ( Site 0510)
Santa Fe
S3000AOL
Argentina
Liverpool Hospital ( Site 1201)
Liverpool
New South Wales
2170
Australia
Southern Medical Day Care Centre ( Site 1200)
Wollongong
New South Wales
2500
Australia
Townsville General Hospital ( Site 1202)
Townsville
Queensland
4814
Australia
Monash Cancer Centre ( Site 1205)
Clayton
Victoria
3168
Australia
Social Medical Center - Otto Wagner Hospital ( Site 1301)
Vienna
State of Vienna
1145
Austria
Innsbruck LKH ( Site 1302)
Innsbruck
Tyrol
6020
Austria
Ordensklinikum Linz GmbH Elisabethinen ( Site 1307)
Linz
Upper Austria
4020
Austria
Klinikum Wels-Grieskirchen ( Site 1304)
Wels
Upper Austria
4600
Austria
Krankenhaus Nord - Klinik Floridsdorf ( Site 1300)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
FG002
Pembro + Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
FG000851 subjects
FG0010 subjects
FG0020 subjects
COMPLETED
FG000591 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG000260 subjects
FG0010 subjects
FG0020 subjects
Type
Comment
Reasons
Failure to Meet Maintenance Randomization Criteria
FG000198 subjects
FG0010 subjects
FG0020 subjects
Death
FG00062 subjects
FG0010 subjects
FG0020 subjects
Maintenance Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG001296 subjectsPer protocol, eligible participants were randomized to one of the maintenance treatment arms. Not all participants from the induction period continued into the randomized maintenance phase.
FG002295 subjectsPer protocol, eligible participants were randomized to one of the maintenance treatment arms. Not all participants from the induction period continued into the randomized maintenance phase.
Pembro + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase): All enrolled participants who were not randomized into maintenance phase Pembro + Olaparib (Maintenance Phase): Intention-to-Treat (ITT) Population which included all randomized participants post induction phase Pembro + Placebo (Maintenance Phase): Intention-to-Treat (ITT) Population which included all randomized participants post induction phase
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Pembrolizumab (Pembro) + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)
Participants received Pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle for 4 cycles PLUS Carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles PLUS investigator's choice of either Paclitaxel (200 mg/m^2 Q3W on Day 1 of each 21-day cycle for 4 cycles or Nab-paclitaxel (100 mg/m^2 Q3W on Days 1, 8, 15 of each 21-day cycle for 4 cycles). Participants may then randomize to one of the blinded treatment arms.
BG001
Pembro + Olaparib (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
BG002
Pembro + Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000260
BG001296
BG002295
BG003851
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG000260
ParticipantsBG001296
ParticipantsBG002295
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000260
ParticipantsBG001296
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000260
ParticipantsBG001296
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000260
ParticipantsBG001296
ParticipantsBG002
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Participants were assessed for ECOG PS: Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature; Grade 2: Ambulatory & capable of all selfcare but unable to carry out any work activities, up & about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled, cannot carry on any selfcare, totally confined to bed or chair or Grade 5: Dead.
Data for this baseline measure were not collected for the induction phase per protocol.
Count of Participants
Participants
Title
Denominators
Categories
Grade 0
ParticipantsBG0000
ParticipantsBG001
Response
Participants last scan before randomization assessed based on blinded independent central review (BICR) Assessment per (Response Evaluation Criteria in Solid Tumors RECIST) 1.1 of the latest evaluable scan obtained prior to randomization.
Data for this baseline measure were not collected for the induction phase per protocol.
Participants were assessed for their PD-L1 tumor expression level by immunohistochemistry assay using tumor tissue from a newly obtained biopsy. Participants with a TPS ≥50% were classified as PD-L1 strongly positive and participants with a TPS <50% were classified as not strongly positive.
Count of Participants
Participants
Title
Denominators
Categories
Tumor Proportion Score (TPS)<50%
ParticipantsBG000260
ParticipantsBG001296
ParticipantsBG002
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
Progression-free Survival (PFS)
Progression-free Survival was defined as the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurred first. Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, progressive disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 is presented. PFS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
The analysis population consisted of all randomized participants.
Posted
Median
95% Confidence Interval
Months
Up to approximately 39 months
ID
Title
Description
OG000
Pembro + Olaparib (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
OG001
Pembro + Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Units
Counts
Participants
OG000296
OG001295
Title
Denominators
Categories
Title
Measurements
OG0008.3(6.7 to 9.7)
OG0015.4(4.1 to 5.6)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.0040
One-sided p-value based on log-rank test stratified by Eastern Cooperative Cancer Group (ECOG) at pre-randomization visit, response at randomization and baseline PD-L1 status.
Hazard Ratio (HR)
0.77
2-Sided
95
0.63
0.93
Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.
Superiority
Primary
Overall Survival (OS)
Overall survival was the time from the date of randomization to death due to any cause. OS is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
The analysis population consisted of all randomized participants.
Posted
Median
95% Confidence Interval
Months
Up to approximately 46 months
ID
Title
Description
OG000
Pembro + Olaparib (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
OG001
Pembro + Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Secondary
Number of Participants With One or More Adverse Events (AEs)
An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The number of participants who reported 1 or more AEs is presented. Per protocol this outcome measure was not planned for the Induction Phase.
Not Posted
Dec 2026
Up to approximately 4 years
Participants
Secondary
Number of Participants Who Discontinued Study Intervention Due to an AE
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. The number of participants who discontinued study intervention due to an AE is presented. Per protocol this outcome measure was not planned for the Induction Phase.
Not Posted
Dec 2026
Up to approximately 4 years
Participants
Secondary
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/ Quality of Life (QoL) (Items 29 and 30) Combined Scale Score
EORTC QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the Global Health Status GHS question "How would you rate your overall health during the past week?" (Item 29) and the QoL question "How would you rate your overall quality of life during the past week?" (Item 30) were each scored on a 7-point scale (1=Very Poor to 7=Excellent), then summed. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score was assessed using a constrained longitudinal data analysis (cLDA) model with the patient-reported outcome (PRO) score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline and Week 24
ID
Title
Description
OG000
Pembro + Olaparib (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Secondary
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 and 30) Scale Score
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Item 29) and QoL score (EORTC QLQ-C30 Item 30). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10- point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.
Posted
Median
95% Confidence Interval
Months
Up to approximately 2 years
ID
Title
Description
OG000
Pembro + Olaparib (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Secondary
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 cough (Item 1) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline and Week 24
ID
Title
Description
OG000
Pembro + Olaparib (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Secondary
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in cough scale score. The TTD for cough (Item 1) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.
Posted
Median
95% Confidence Interval
Months
Up to approximately 2 years
ID
Title
Description
OG000
Pembro + Olaparib (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Secondary
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-LC13 chest pain (Item 10) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline and Week 24
ID
Title
Description
OG000
Pembro + Olaparib (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Secondary
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Chest Pain (Item 10) Scale Score
The EORTC QLQ-LC13 is a lung cancer specific supplemental questionnaire used in combination with the EORTC QLQ-C30 questionnaire. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in chest pain scale score. The TTD for chest pain (Item 10) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.
Posted
Median
95% Confidence Interval
Months
Up to approximately 2 years
ID
Title
Description
OG000
Pembro + Olaparib (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Secondary
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score will be presented. A lower score indicates a better outcome. The change from baseline in EORTC QLQ-C30 dyspnea (Item 8) score is presented. Change from baseline score was assessed using a cLDA model with the PRO score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline and Week 24
ID
Title
Description
OG000
Pembro + Olaparib (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Secondary
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Dyspnea (Item 8) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Item 8 scale score. The TTD for dyspnea (Item 8) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.
Posted
Median
95% Confidence Interval
Months
Up to approximately 2 years
ID
Title
Description
OG000
Pembro + Olaparib (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Secondary
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score is presented. Change from baseline score was assessed using a constrained longitudinal data analysis (cLDA) model with the patient-reported outcome (PRO) score as the response variable, and treatment, time, treatment-by-time interaction, and clinical study stratification factors as covariates. Per protocol this outcome measure was not planned for the Induction Phase.
The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.
Posted
Least Squares Mean
95% Confidence Interval
Score on Scale
Baseline and Week 24
ID
Title
Description
OG000
Pembro + Olaparib (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Secondary
Time to True Deterioration (TTD) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (Items 1 to 5) Scale Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. TTD was defined as the time from baseline (at randomization) to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in physical functioning Items 1 to 5 scale scores. The TTD for physical functioning (Item 1-5) is presented. TTD is reported based on the non-parametric Kaplan-Meier method. Per protocol this outcome measure was not planned for the Induction Phase.
The analysis population consists of all randomized participants who had at least one PRO assessment available and had received at least one dose of study medication.
Posted
Median
95% Confidence Interval
Months
Up to approximately 2 years
ID
Title
Description
OG000
Pembro + Olaparib (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Time Frame
Up to approximately 4 years
Description
Mortality includes all enrolled participants regardless of treatment status. AEs include all participants who received ≥1 dose of study drug, counted in the latest arm for which a participant received drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" not related to study treatment are excluded as AEs.
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
Pembro + Carboplatin + Paclitaxel or Nab-Paclitaxel (Induction Phase)
Participants received Pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle for 4 cycles PLUS Carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles PLUS investigator's choice of either Paclitaxel (200 mg/m^2 Q3W on Day 1 of each 21-day cycle for 4 cycles or Nab-paclitaxel (100 mg/m^2 Q3W on Days 1, 8, 15 of each 21-day cycle for 4 cycles). Participants may then randomize to one of the blinded treatment arms.
101
851
220
851
787
851
EG001
Pembro+Olaparib (Maintenance Phase )
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral olaparib 300 mg twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with stable disease (SD), complete response (CR), or partial response (PR), and without a current adverse event (AE), may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
188
296
97
294
265
294
EG002
Pembro+Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
189
295
77
292
240
292
EG003
Pembro + Olaparib (Second Course Pembro Only)
Eligible participants who received 35 cycles of Pembrolizumab and progressed with SD, PR, or CR in either arm were eligible for an optional 1 additional year (17 cycles) of Pembrolizumab.
0
7
2
7
4
7
EG004
Pembro + Placebo (Second Course Pembro Only)
Eligible participants who received 35 cycles of Pembrolizumab and progressed with SD, PR, or CR in either arm were eligible for an optional 1 additional year (17 cycles) of Pembrolizumab.
2
9
1
9
6
9
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected851 at risk
EG00110 events10 affected294 at risk
EG0022 events2 affected292 at risk
EG0030 events0 affected7 at risk
EG0040 events0 affected9 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG00014 events14 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG00011 events11 affected851 at risk
EG0012 events2 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG0006 events6 affected851 at risk
EG0014 events4 affected294 at risk
EG0023 events3 affected292 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected851 at risk
EG0013 events3 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0012 events2 affected294 at risk
EG0022 events2 affected292 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0013 events3 affected294 at risk
EG0022 events2 affected292 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Cataract
Eye disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00010 events10 affected851 at risk
EG0013 events3 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Asthenia
General disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Chest discomfort
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Death
General disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected851 at risk
EG0012 events2 affected294 at risk
EG0022 events2 affected292 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG00010 events8 affected851 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0006 events6 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0008 events8 affected851 at risk
EG0019 events9 affected294 at risk
EG0022 events2 affected292 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected851 at risk
EG00110 events10 affected294 at risk
EG0028 events8 affected292 at risk
EG003
Carbuncle
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0012 events2 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Device related infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Hepatitis C
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Herpes zoster disseminated
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Lung abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG00041 events36 affected851 at risk
EG00114 events13 affected294 at risk
EG00212 events11 affected292 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0005 events5 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Septic shock
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected851 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0023 events1 affected292 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0012 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Shoulder fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Traumatic lung injury
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0022 events1 affected292 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0022 events1 affected292 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Troponin increased
Investigations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected851 at risk
EG0010 events0 affected294 at risk
EG0022 events2 affected292 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0022 events1 affected292 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Adenocarcinoma gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Cerebral haematoma
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0003 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Facial nerve disorder
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0012 events2 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0009 events8 affected851 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0022 events2 affected292 at risk
EG003
Nephropathy
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected851 at risk
EG0010 events0 affected294 at risk
EG0022 events2 affected292 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 events3 affected851 at risk
EG0011 events1 affected294 at risk
EG0024 events3 affected292 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0005 events5 affected851 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected851 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0017 events7 affected294 at risk
EG0023 events3 affected292 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected851 at risk
EG0012 events2 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0005 events5 affected851 at risk
EG0013 events3 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected851 at risk
EG0011 events1 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Pemphigoid
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Peripheral artery thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0021 events1 affected292 at risk
EG003
Superior vena cava syndrome
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0011 events1 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Cardiac ventricular thrombosis
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Chest pain
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
General physical health deterioration
General disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Sudden cardiac death
General disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Anaphylactic shock
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0003 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Mediastinitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Meningitis cryptococcal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Sepsis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0005 events5 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Eastern Cooperative Oncology Group performance status worsened
Investigations
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0005 events3 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Steroid diabetes
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Osteoporotic fracture
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Rectal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Seizure
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Stupor
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Syncope
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Toxic neuropathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Depression
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Autoimmune nephritis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Orchitis noninfective
Reproductive system and breast disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Bronchial haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Sputum increased
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Embolism
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Hypotension
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Subclavian artery stenosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG000432 events369 affected851 at risk
EG001215 events130 affected294 at risk
EG00269 events45 affected292 at risk
EG0031 events1 affected7 at risk
EG0041 events1 affected9 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG000299 events168 affected851 at risk
EG001115 events44 affected294 at risk
EG00219 events13 affected292 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG00028 events23 affected851 at risk
EG00139 events21 affected294 at risk
EG00213 events11 affected292 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG000520 events279 affected851 at risk
EG001118 events57 affected294 at risk
EG00225 events16 affected292 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 26.0
Systematic Assessment
EG000314 events200 affected851 at risk
EG001127 events56 affected294 at risk
EG00243 events19 affected292 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 26.0
Systematic Assessment
EG00025 events25 affected851 at risk
EG00124 events23 affected294 at risk
EG00238 events34 affected292 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG000165 events147 affected851 at risk
EG00130 events26 affected294 at risk
EG00230 events29 affected292 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG000148 events112 affected851 at risk
EG00132 events23 affected294 at risk
EG00249 events33 affected292 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG000346 events215 affected851 at risk
EG00198 events69 affected294 at risk
EG00251 events35 affected292 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00075 events66 affected851 at risk
EG00134 events26 affected294 at risk
EG00215 events11 affected292 at risk
EG003
Asthenia
General disorders
MedDRA 26.0
Systematic Assessment
EG000138 events115 affected851 at risk
EG00150 events42 affected294 at risk
EG00247 events37 affected292 at risk
EG003
Fatigue
General disorders
MedDRA 26.0
Systematic Assessment
EG000136 events105 affected851 at risk
EG00136 events32 affected294 at risk
EG00244 events40 affected292 at risk
EG003
Pyrexia
General disorders
MedDRA 26.0
Systematic Assessment
EG00083 events74 affected851 at risk
EG00121 events18 affected294 at risk
EG00220 events16 affected292 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0006 events6 affected851 at risk
EG00113 events13 affected294 at risk
EG00220 events19 affected292 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG00026 events23 affected851 at risk
EG00119 events17 affected294 at risk
EG00221 events11 affected292 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG00059 events54 affected851 at risk
EG00132 events25 affected294 at risk
EG00250 events29 affected292 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG00045 events39 affected851 at risk
EG00127 events25 affected294 at risk
EG00242 events27 affected292 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 26.0
Systematic Assessment
EG00040 events38 affected851 at risk
EG00131 events21 affected294 at risk
EG00233 events22 affected292 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 26.0
Systematic Assessment
EG00037 events31 affected851 at risk
EG00141 events26 affected294 at risk
EG00239 events17 affected292 at risk
EG003
Weight decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG00037 events36 affected851 at risk
EG00114 events14 affected294 at risk
EG00216 events15 affected292 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG000166 events140 affected851 at risk
EG00162 events54 affected294 at risk
EG00253 events47 affected292 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG00035 events33 affected851 at risk
EG00151 events24 affected294 at risk
EG00237 events21 affected292 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG00034 events31 affected851 at risk
EG00124 events15 affected294 at risk
EG00240 events22 affected292 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG00050 events41 affected851 at risk
EG0015 events5 affected294 at risk
EG00229 events18 affected292 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG000102 events65 affected851 at risk
EG00135 events29 affected294 at risk
EG00247 events32 affected292 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG00016 events15 affected851 at risk
EG00124 events20 affected294 at risk
EG00223 events21 affected292 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG000114 events75 affected851 at risk
EG00110 events9 affected294 at risk
EG00218 events16 affected292 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG00026 events25 affected851 at risk
EG00121 events17 affected294 at risk
EG00211 events11 affected292 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG00020 events19 affected851 at risk
EG00127 events20 affected294 at risk
EG00226 events21 affected292 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG00035 events35 affected851 at risk
EG00146 events36 affected294 at risk
EG00240 events37 affected292 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG00038 events37 affected851 at risk
EG00133 events29 affected294 at risk
EG00235 events32 affected292 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG00028 events25 affected851 at risk
EG00110 events10 affected294 at risk
EG00223 events17 affected292 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG00059 events55 affected851 at risk
EG00130 events22 affected294 at risk
EG00230 events27 affected292 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG00066 events63 affected851 at risk
EG00123 events22 affected294 at risk
EG00231 events24 affected292 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 26.0
Systematic Assessment
EG00018 events18 affected851 at risk
EG0018 events8 affected294 at risk
EG0028 events7 affected292 at risk
EG003
Malaise
General disorders
MedDRA 26.0
Systematic Assessment
EG00035 events27 affected851 at risk
EG0014 events4 affected294 at risk
EG0023 events2 affected292 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG00011 events10 affected851 at risk
EG0014 events4 affected294 at risk
EG0026 events4 affected292 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected851 at risk
EG0011 events1 affected294 at risk
EG0022 events2 affected292 at risk
EG003
Influenza
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0004 events4 affected851 at risk
EG0014 events4 affected294 at risk
EG0024 events4 affected292 at risk
EG003
Lower respiratory tract infection viral
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG00010 events10 affected851 at risk
EG00111 events9 affected294 at risk
EG0029 events7 affected292 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected851 at risk
EG0010 events0 affected294 at risk
EG0025 events4 affected292 at risk
EG003
Platelet count decreased
Investigations
MedDRA 26.0
Systematic Assessment
EG00019 events15 affected851 at risk
EG00111 events10 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 26.0
Systematic Assessment
EG0008 events8 affected851 at risk
EG0018 events8 affected294 at risk
EG00214 events9 affected292 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 26.0
Systematic Assessment
EG0002 events2 affected851 at risk
EG0018 events8 affected294 at risk
EG0028 events6 affected292 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG000130 events120 affected851 at risk
EG0017 events7 affected294 at risk
EG0027 events6 affected292 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG00065 events60 affected851 at risk
EG0017 events5 affected294 at risk
EG0026 events6 affected292 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG00065 events62 affected851 at risk
EG0011 events1 affected294 at risk
EG0025 events5 affected292 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 26.0
Systematic Assessment
EG00044 events43 affected851 at risk
EG00114 events10 affected294 at risk
EG0029 events8 affected292 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG00011 events11 affected851 at risk
EG0016 events5 affected294 at risk
EG0022 events2 affected292 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 26.0
Systematic Assessment
EG000279 events279 affected851 at risk
EG0011 events1 affected294 at risk
EG0025 events5 affected292 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected851 at risk
EG0010 events0 affected294 at risk
EG0020 events0 affected292 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If publication activity was not directed by the Sponsor, the investigator agreed to submit all manuscripts or abstracts to the Sponsor before submission. This allowed the Sponsor to protect proprietary information and to provide comments.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
One-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.
Hazard Ratio (HR)
1.01
2-Sided
95
0.83
1.24
Based on Cox regression model with Efron's method of tie handling and with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization and baseline PD-L1 status.
Superiority
OG001
Pembro + Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Units
Counts
Participants
OG000293
OG001291
Title
Denominators
Categories
Title
Measurements
OG000-1.24(-3.68 to 1.19)
OG001-1.62(-4.11 to 0.88)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.8238
Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
Difference in LS Means
0.37
2-Sided
95
-2.91
3.66
Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
Other
OG001
Pembro + Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Units
Counts
Participants
OG000285
OG001283
Title
Denominators
Categories
Title
Measurements
OG00029.08(17.94 to NA)Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
OG00129.01(12.55 to NA)Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.3083
Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization Visit, response at randomization, and baseline PD-L1 expression.
Hazard Ratio (HR)
0.87
2-Sided
95
0.66
1.14
Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization Visit, response at randomization, and baseline PD-L1 expression.
Other
OG001
Pembro + Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Units
Counts
Participants
OG000293
OG001291
Title
Denominators
Categories
Title
Measurements
OG0002.42(-0.93 to 5.77)
OG0010.74(-2.69 to 4.17)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.4686
Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
Difference in Least Square Means
1.68
2-Sided
95
-2.87
6.23
Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
Other
OG001
Pembro + Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Units
Counts
Participants
OG000285
OG001283
Title
Denominators
Categories
Title
Measurements
OG00024.18(15.64 to NA)Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
OG001NA(16.56 to NA)Median and Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.9174
Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.
Hazard Ratio (HR)
1.01
2-Sided
95
0.76
1.35
Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.
Other
OG001
Pembro + Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Units
Counts
Participants
OG000293
OG001291
Title
Denominators
Categories
Title
Measurements
OG0006.35(3.95 to 8.76)
OG0012.52(0.06 to 4.98)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.0245
Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
Difference in Least Square Means
3.83
2-Sided
95
0.50
7.16
Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
Other
OG001
Pembro + Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Units
Counts
Participants
OG000285
OG001283
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median, Lower and Upper Limit not reached at time of data cut-off due to insufficient number of participants with an event.
OG001NA(NA to NA)Median, Lower and Upper Limit not reached at time of data cut-off due to insufficient number of participants with an event.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.2133
Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.
Hazard Ratio (HR)
1.24
2-Sided
95
0.88
1.75
Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.
Other
OG001
Pembro + Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Units
Counts
Participants
OG000293
OG001291
Title
Denominators
Categories
Title
Measurements
OG000-1.08(-4.49 to 2.34)
OG001-1.25(-4.74 to 2.24)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.9381
Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
Hazard Ratio (HR)
0.18
2-Sided
95
-4.27
4.62
Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
Other
OG001
Pembro + Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Units
Counts
Participants
OG000285
OG001283
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median, Lower and Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
OG001NA(14.72 to NA)Median and Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.8464
Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.
Hazard Ratio (HR)
0.97
2-Sided
95
0.72
1.31
Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.
Other
OG001
Pembro + Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Units
Counts
Participants
OG000285
OG001283
Title
Denominators
Categories
Title
Measurements
OG000-2.04(-4.38 to 0.31)
OG0010.77(-1.62 to 3.17)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
t-test, 2 sided
0.0870
Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
Difference in Least Square Means
-2.81
2-Sided
95
-6.02
0.41
Based on cLDA model with the PRO scores as the response variable with covariates for treatment by time interaction, stratification factors, response at randomization, and baseline PD-L1 expression as covariates.
Other
OG001
Pembro + Placebo (Maintenance Phase)
This arm includes participants who randomized following completion of the induction period. After the induction period, participants received pembrolizumab IV on Day 1 of each 21-day for up to 31 cycles PLUS matching maintenance olaparib placebo twice daily. In the Maintenance Phase, the participant continued to receive maintenance olaparib placebo until centrally verified progressive disease, physician decision or intolerable toxicity.
Participants treated with pembrolizumab who completed 35 cycles of pembrolizumab during the study with SD, CR, or PR, and without a current AE, may have been eligible for retreatment with up to an additional 17 cycles (approximately 1 year) of pembrolizumab if they experienced radiographic disease progression after stopping treatment in the Maintenance Phase.
Units
Counts
Participants
OG000285
OG001283
Title
Denominators
Categories
Title
Measurements
OG00022.80(10.05 to NA)Upper Limit not reached at time of data cut-off due to insufficient number of participants with an event.
OG001NA(27.50 to NA)Median and Upper Limit not reached at time of data cut-off due to insufficient number of participants with an event.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
0.0020
Two-sided p-value based on log-rank test stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.
Hazard Ratio (HR)
1.60
2-Sided
95
1.18
2.16
Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by ECOG at pre-randomization visit, response at randomization, and baseline PD-L1 expression.