A Study of Niraparib Combination Therapies for the Treatm... | NCT03431350 | Trialant
NCT03431350
Sponsor
Janssen Research & Development, LLC
Status
Active, not recruiting
Last Update Posted
Jul 7, 2026Actual
Enrollment
136Actual
Phase
Phase 2
Conditions
Prostatic Neoplasms, Castration-Resistant
Interventions
Niraparib 200 mg
Cetrelimab 240 mg
Cetrelimab 480 mg
Abiraterone acetate 1000 mg
Prednisone 5 mg
Countries
United States
Belgium
Canada
Israel
Italy
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03431350
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108406
Secondary IDs
ID
Type
Description
Link
64091742PCR2002
Other Identifier
Janssen Research & Development, LLC
2017-003552-23
EudraCT Number
Brief Title
A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Official Title
A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Acronym
QUEST
Organization
Janssen Research & Development, LLCINDUSTRY
Status Module
Record Verification Date
Jul 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 2, 2018Actual
Primary Completion Date
Aug 31, 2021Actual
Completion Date
Dec 31, 2026Estimated
First Submitted Date
Feb 6, 2018
First Submission Date that Met QC Criteria
Feb 6, 2018
First Posted Date
Feb 13, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Sep 7, 2023
Results First Submitted that Met QC Criteria
Oct 25, 2023
Results First Posted Date
Nov 18, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 29, 2022
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Nov 18, 2023Actual
Last Update Submitted Date
Jul 2, 2026
Last Update Posted Date
Jul 7, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Research & Development, 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 purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and abiraterone acetate (AA) in combination (Combination 3) in participants with metastatic castration-resistant prostate cancer (mCRPC).
Detailed Description
This multicenter study will evaluate safety and efficacy of niraparib in combination with other anti-cancer agents. Combination 1 will combine niraparib with the anti-programmed cell death protein (PD)-1 monoclonal antibody cetrelimab, in participants with mCRPC. Combination 1 has 2 parts: in Part 1 (dose selection), participants will be enrolled to establish RP2D doses of niraparib and cetrelimab; and Part 2 (dose expansion) will evaluate the combination therapy in an expanded number of participants into 2 cohorts (biomarker positive or biomarker negative). Combination 2 will combine niraparib with abiraterone acetate plus prednisone (AA-P) in mCRPC participants with DNA-repair gene defects (DRD). Combination 3 will evaluate the relative bioavailability (BA) of niraparib and AA in combination. In a pharmacokinetics (PK) assessment phase, niraparib and AA will be administered, and in an extension phase, niraparib and AA-P will be administered. Combinations 1 and 2 will have 5 phases: A Pre-screening Phase, a Screening Phase, a Treatment Phase, a Follow-up Phase, and a Long-term Extension (LTE) Phase; Combination 3 has 3 phases: A Screening Phase, A PK Assessment Phase, an Extension Phase (including LTE phase). Study evaluations will include efficacy, PK, PK/pharmacodynamics, biomarkers, safety and tolerability.
Dose regimen 1: The participants will receive niraparib 200 milligram (mg) orally once daily in combination with cetrelimab 240 mg intravenously (IV) once every 2 weeks. Dose regimen 2: The participants will receive niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV once every 4 weeks in 28-day treatment cycles until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. The safety evaluation team (SET) will determine if an additional cohort is necessary, based on the data from dose regimens 1 and 2. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.
Participants will be assigned to either Cohort 1A (Biomarker [BM] positive [+]) or Cohort 1B (BM negative [-]) and will receive established RP2D of cetrelimab and niraparib, in Part 2 until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. A futility analysis will be performed for the Cohort 1B after 10 BM- participants are enrolled in Part 2. This cohort will be closed if the response is less than predetermined response rate as outlined in the protocol. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.
Participants will be assigned to one of 4 cohorts based on biomarker status - Cohort 2A (BRCA biallelic loss), 2B (other DRD biallelic loss), 2C (BRCA monoallelic loss), or 2D (other DRD monoallelic loss), and will receive niraparib 200 mg once daily in combination with abiraterone acetate 1000 mg (4*250 mg) plus 10 mg prednisone (5 mg twice daily) throughout treatment phase. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Niraparib 200 mg
Drug
Participants will receive niraparib 200 mg orally.
Combination 1: Part 1: Number of Participants With Specified Toxicity
Number of participants with specified toxicity during Cycle 1 was reported. Only toxicities that occurred during safety evaluation period(defined as first 28 days of treatment-Cycle 1 of Part 1) was used for analysis of specified toxicities and for dose reduction decisions. Toxicities were graded for severity as per NCI-CTCAE, version 4.03. Safety evaluation criteria were: Any Grade(G) >=3 non-hematological toxicity without anorexia, or constipation, fatigue improved to G<=2 in <7 days, vomiting and diarrhea resolved in <=3 days, laboratory abnormalities with hospitalization, tumor flare improved to G<=2 in <=7 days, elevation in AST/ALT for <=7 days and G3 hypertension controlled by medical therapy; any treatment-related(TR)G4 or G>=3 thrombocytopenia required platelet transfusion; Any TR G4 neutropenia >=7 days or G3 or 4 neutropenia with infection/fever >38.5 degrees Celsius; Any TR SAE or intolerable toxicity.
Cycle 1 (28 days)
Combination 1: Part 2: Objective Response Rate (ORR)
ORR of soft tissue (visceral or nodal disease) was defined as percentage of participants with measurable disease who achieved a best response of either complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with no evidence of bone progression according to prostate cancer working group 3 (PCWG3) criteria.
Up to 37 months
Combination 2: Composite Response Rate (RR)
Composite response rate was defined as the percentage of participants who had a composite response which is defined as one of the following PCWG3 criteria: Objective response (percentage of participants with measurable disease who achieved a best response of either CR or PR as assessed by RECIST 1.1 with no evidence of bone progression according to PCWG3 criteria) (confirmed per RECIST 1.1), or; circulating tumor cells (CTC) response: defined as CTC=0 per 7.5 milliliters (mL) of blood at 8 weeks for participants who had CTC greater than or equal to (>=) 1 at baseline or CTC less than (<) 5 per 7.5 mL with CTC >=5 at baseline, confirmed by a second consecutive value obtained 4 or more weeks later, or prostate-specific antigen (PSA) declined of >=50 percentage (%), measured twice 3 to 4 weeks apart. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.
Secondary Outcomes
Measure
Description
Time Frame
Combination 1: Parts 1 and 2: Plasma Concentrations of Niraparib
Day 1
Combination 1: Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Niraparib
Day 1
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria for Combination 3:
Diagnosed with mCRPC, who in the opinion of the investigator may benefit from treatment in Combination 3 of this study
Able to continue gonadotropin releasing hormone analogue (GnRHa) therapy during the study if not surgically castrate (that is, subjects who has not undergone bilateral orchiectomy).
Eastern Cooperative Oncology Group Performance Status (ECOG PS) of less than or equal to (<=) 1
Toxicity associated with prior chemotherapy or radiotherapy has resolved to Grade <= 1 (except alopecia or Grade <= 2 neuropathy) at screening
Participant must agree not to donate sperm while on study treatment, and for 3 months following the last dose of study treatment
Exclusion Criteria:
History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
Active malignancies (that is, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: non-muscle invasive bladder cancer; skin cancer (non-melanoma or melanoma); breast cancer; malignancy that is considered cured with minimal risk of recurrence
Active infection requiring systemic therapy
Allergies, hypersensitivity, or intolerance to niraparib or the corresponding excipients
Combination 3:
Symptomatic brain metastases
Prior disease progression during combination treatment with AA and poly (adenosine diphosphate [ADP]-ribose) polymerase inhibitor (PARPi). Prior discontinuation of treatment with AA or PARPi due to AA- or PARPi-related toxicity
Accepts Healthy Volunteers
No
Sex
Male
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Urological Associates of Southern Arizona, P.C.
Tucson
Arizona
85741
United States
The Urology Center of Colorado
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
In Combination 2, one participant who was homologous recombination repair (HRR) negative was erroneously enrolled to Cohort 2C (BRCA monoallelic loss) and thus was not included in the Intent-to-Treat (ITT) Population for the efficacy analysis. but was included in the safety analysis. This participant data were presented in participant flow, baseline characteristics and adverse events section. Data reported based on primary completion date, i.e., August 31, 2021.
Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 3, 2021
Sep 7, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
France
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Niraparib 200 mg
Drug: Abiraterone acetate 1000 mg
Drug: Prednisone 5 mg
Combination 3: Niraparib + AA-P
Experimental
Participants will be assigned to one of three cohorts to receive AA-P with or without niraparib. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.
Combination 1: Part 2: Number of Participants With Adverse Events (AEs)
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.
Up to 37 months
Combination 2: Number of Participants With Adverse Events (AEs)
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.
Up to 31 months
Combination 1: Part 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death).
Up to 37 months
Combination 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the NCI-CTCAE as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death).
Up to 31 months
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib and Abiraterone Acetate After a Single Dose
Cmax is defined as maximum observed plasma concentration of niraparib and abiraterone acetate (AA) after a single dose.
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose
Cmax/dose of niraparib was defined as maximum observed plasma concentration of niraparib Cmax normalized by the dose of niraparib administered with AA after a single dose.
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose
AUC(0-168 hours) was defined as area under the plasma concentration-time curve from time zero to 168 hours of Niraparib administered with AA After a single dose.
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/Dose) of Niraparib Administered With AA After a Single Dose
AUC0(168 hours)/dose was defined as area under the plasma concentration-time curve for niraparib from time 0 to 168 hours of niraparib administered with AA after a single dose.
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 1: Parts 1 and 2: Time to Reach the Maximum Plasma Concentration (Tmax) of Niraparib
Day 1
Combination 1: Parts 1 and 2: Minimum Observed (Predose) Concentration Following Multiple Dosing (Ctrough) of Niraparib
Day 1
Combination 1: Parts 1 and 2: Number of Participants With Anti-drug Antibodies of Niraparib
From baseline up to end of study (6 years 10 months)
Combination 1: Part 2 and Combination 2: Circulating Tumor Cells (CTC) Response
From baseline up to end of study (6 years 10 months)
Combination 1: Part 2: Composite Response Rate
From baseline up to end of study (6 years 10 months)
Combination 2: Objective Response Rate (ORR)
From baseline up to end of study (6 years 10 months)
Combination 1: Part 2 and Combination 2: Duration of Objective Response
From baseline up to end of study (6 years 10 months)
Combination 1: Part 2 and Combination 2: Overall Survival
From baseline up to end of study (6 years 10 months)
Combination 3: Cmax of Niraparib and Abiraterone Acetate After a Single Dose For Low-strength FDC
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose for Low-strength FDC
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose For Low-strength FDC
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/Dose) of Niraparib Administered With AA After a Single Dose For Low-strength FDC
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Number of Participants With Adverse Events
From baseline up to end of study (6 years 10 months)
Combination 3: Number of Participants With Clinical Laboratory Parameters
From baseline up to end of study (6 years 10 months)
Denver
Colorado
80211
United States
Mayo Clinic - Division Of Hematology/oncology
Jacksonville
Florida
32224
United States
First Urology, PSC
Jeffersonville
Indiana
47130
United States
Chesapeake Urology Research Associates
Towson
Maryland
21204
United States
Michigan Institute of Urology
Troy
Michigan
48084
United States
New York Oncology Hematology
Albany
New York
12208
United States
Memorial Sloan Kettering Cancer Center 1
Harrison
New York
10604
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Thomas Jefferson University
Philadelphia
Pennsylvania
19107
United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh
Pennsylvania
15232
United States
MUSC-Hollings Cancer Center
Charleston
South Carolina
29425
United States
Carolina Urologic Research Center
Myrtle Beach
South Carolina
29572
United States
Urology Associates
Nashville
Tennessee
37209
United States
Houston Metro Urology
Houston
Texas
77027
United States
The University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Utah Cancer Specialists
Salt Lake City
Utah
84106
United States
Urology of Virginia, PLCC
Virginia Beach
Virginia
23462
United States
University of Wisconsin Carbone Cancer Center
Madison
Wisconsin
5379200
United States
OLV Ziekenhuis Aalst
Aalst
9300
Belgium
ZNA Middelheim
Antwerp
2020
Belgium
ULB Hôpital Erasme
Brussels
1070
Belgium
Universitair Ziekenhuis Gent
Ghent
9000
Belgium
Az Groeninge
Kortrijk
8500
Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège
B-4000
Belgium
Southern Alberta Institute of Urology / Prostate Cancer Centre
Calgary
Alberta
T2V 1P9
Canada
British Columbia Cancer Agency
Vancouver
British Columbia
V5Z4E6
Canada
Princess Margaret Cancer Centre University Health Network
Toronto
Ontario
M5G2M9
Canada
Centre de Recherche du CHUM
Montreal
Quebec
H2X 0A9
Canada
Asaf Harofe Medical Center
Beer Yaakov
60930
Israel
Soroka Hospital
Beersheba
85101
Israel
Rambam Medical Center
Haifa
31096
Israel
Rabin Medical Center
Petah Tikva
49100
Israel
Sheba Medical Center Tel Hashomer
Ramat Gan
52621
Israel
Azienda Ospedaliera Universitaria Careggi di Firenze
Florence
50134
Italy
Azienda Ospedaliera ''Vito Fazzi''
Lecce
73100
Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan
20162
Italy
IRCCS-Fondazione Pascale
Naples
80131
Italy
UOC Oncologia Ospedale Provinciale di Macerata
Province of Macerata
62100
Italy
Hosp. de La Santa Creu I Sant Pau
Barcelona
08025
Spain
Hospital Vall D'Hebron
Barcelona
8035
Spain
Hosp. Univ. de La Princesa
Madrid
28006
Spain
Hosp Univ Fund Jimenez Diaz
Madrid
28040
Spain
Hosp Univ Hm Sanchinarro
Madrid
28050
Spain
Hosp Virgen de La Victoria
Málaga
29010
Spain
Royal United Hospital
Bath
BA1 3NG
United Kingdom
University College London Hospitals
London
WC1E 6BT
United Kingdom
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
The Royal Marsden NHS Trust Sutton
Sutton
SM2 5PT
United Kingdom
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and were BM+ received established recommended Phase 2 dose (RP2D) of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and were BM- received established RP2D of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alterations (breast cancer gene [BRCA] biallelic loss [2A]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone (P) 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alterations (BRCA monoallelic loss [2C]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss [2D]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
FG008
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA
Participants with mCRPC (regardless of HRR BM status) received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as single agent (SA) orally from Cycle 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (Pharmacokinetic [PK] Assessment Phase), Participants had the option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 as fixed-dose combination 1 (FDC1) regular-strength (RS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC2 RS tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Participants with mCRPC received a single oral dose of niraparib 100 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC1 low strength (LS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and were BM+ received established recommended Phase 2 dose (RP2D) of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and were BM- received established RP2D of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alterations (breast cancer gene [BRCA] biallelic loss [2A]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone (P) 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alterations (BRCA monoallelic loss [2C]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss [2D]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
BG008
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA
Participants with mCRPC (regardless of HRR BM status) received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as single agent (SA) orally from Cycle 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (Pharmacokinetic [PK] Assessment Phase), Participants had the option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 as fixed-dose combination 1 (FDC1) regular-strength (RS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC2 RS tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Participants with mCRPC received a single oral dose of niraparib 100 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC1 low strength (LS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0016
BG00221
BG00311
BG0048
BG0059
BG0066
BG0071
BG00817
BG00917
BG01017
BG01117
BG012136
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00065.3± 7.15
BG00166.7± 12.56
BG00268.1± 6.6
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
BELGIUM
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Combination 1: Part 1: Number of Participants With Specified Toxicity
Number of participants with specified toxicity during Cycle 1 was reported. Only toxicities that occurred during safety evaluation period(defined as first 28 days of treatment-Cycle 1 of Part 1) was used for analysis of specified toxicities and for dose reduction decisions. Toxicities were graded for severity as per NCI-CTCAE, version 4.03. Safety evaluation criteria were: Any Grade(G) >=3 non-hematological toxicity without anorexia, or constipation, fatigue improved to G<=2 in <7 days, vomiting and diarrhea resolved in <=3 days, laboratory abnormalities with hospitalization, tumor flare improved to G<=2 in <=7 days, elevation in AST/ALT for <=7 days and G3 hypertension controlled by medical therapy; any treatment-related(TR)G4 or G>=3 thrombocytopenia required platelet transfusion; Any TR G4 neutropenia >=7 days or G3 or 4 neutropenia with infection/fever >38.5 degrees Celsius; Any TR SAE or intolerable toxicity.
The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.
Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Units
Counts
Participants
OG0005
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Primary
Combination 1: Part 2: Objective Response Rate (ORR)
ORR of soft tissue (visceral or nodal disease) was defined as percentage of participants with measurable disease who achieved a best response of either complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with no evidence of bone progression according to prostate cancer working group 3 (PCWG3) criteria.
Intent-to-Treat (ITT) analysis set included all participants who had at least 1 dose of both study drugs at the selected RP2D in Combination 1: Part 2 of study. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.
Participants with mCRPC and were BM+ received established recommended Phase 2 dose (RP2D) of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and were BM- received established RP2D of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Primary
Combination 2: Composite Response Rate (RR)
Composite response rate was defined as the percentage of participants who had a composite response which is defined as one of the following PCWG3 criteria: Objective response (percentage of participants with measurable disease who achieved a best response of either CR or PR as assessed by RECIST 1.1 with no evidence of bone progression according to PCWG3 criteria) (confirmed per RECIST 1.1), or; circulating tumor cells (CTC) response: defined as CTC=0 per 7.5 milliliters (mL) of blood at 8 weeks for participants who had CTC greater than or equal to (>=) 1 at baseline or CTC less than (<) 5 per 7.5 mL with CTC >=5 at baseline, confirmed by a second consecutive value obtained 4 or more weeks later, or prostate-specific antigen (PSA) declined of >=50 percentage (%), measured twice 3 to 4 weeks apart. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.
ITT analysis set included all participants who had at least 1 dose of both study drugs at the selected RP2D in Part 2 of study. In Combination 2, one participant who was HRR negative was erroneously enrolled to Cohort 2C (BRCA monoallelic loss) and was presented under arm named "Combination 2: Cohort 2C: HRR negative: Niraparib + Abiraterone Acetate + Prednisone". Due to erroneous enrollment, this participant was not included in the ITT population for the efficacy analysis of this endpoint.
Participants with mCRPC and HRR gene alterations (breast cancer gene [BRCA] biallelic loss [2A]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone (P) 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Primary
Combination 1: Part 2: Number of Participants With Adverse Events (AEs)
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.
The safety analysis set included all randomized participants who received at least 1 dose of study drug. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.
Participants with mCRPC and were BM+ received established recommended Phase 2 dose (RP2D) of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and were BM- received established RP2D of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Primary
Combination 2: Number of Participants With Adverse Events (AEs)
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.
The safety analysis set included all randomized participants who received at least 1 dose of study drug. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.
Participants with mCRPC and HRR gene alterations (breast cancer gene [BRCA] biallelic loss [2A]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone (P) 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alterations (BRCA monoallelic loss [2C]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Primary
Combination 1: Part 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death).
The safety analysis set included all randomized participants who received at least 1 dose of study drug. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.
Participants with mCRPC and were BM+ received established recommended Phase 2 dose (RP2D) of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Primary
Combination 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the NCI-CTCAE as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death).
The safety analysis set included all randomized participants who received at least 1 dose of study drug. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.
Participants with mCRPC and HRR gene alterations (breast cancer gene [BRCA] biallelic loss [2A]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone (P) 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
OG001
Primary
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib and Abiraterone Acetate After a Single Dose
Cmax is defined as maximum observed plasma concentration of niraparib and abiraterone acetate (AA) after a single dose.
Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of both study agents (either as a fixed dose combination [FDC] or single agent combination [SAC]) and had at least 1 concentration value. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.
Posted
Mean
Standard Deviation
Nanograms per milliliter (ng/mL)
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
ID
Title
Description
OG000
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA
Participants with mCRPC (regardless of HRR BM status) received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as single agent (SA) orally from Cycle 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (Pharmacokinetic [PK] Assessment Phase), Participants had the option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose
Cmax/dose of niraparib was defined as maximum observed plasma concentration of niraparib Cmax normalized by the dose of niraparib administered with AA after a single dose.
PK analysis set included all participants who received at least 1 dose of both study agents (either as a FDC or SAC) and had at least 1 concentration value. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.
Posted
Mean
Standard Deviation
nanograms per milliliter per milligram
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
ID
Title
Description
OG000
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA
Participants with mCRPC (regardless of HRR BM status) received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as single agent (SA) orally from Cycle 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (Pharmacokinetic [PK] Assessment Phase), Participants had the option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose
AUC(0-168 hours) was defined as area under the plasma concentration-time curve from time zero to 168 hours of Niraparib administered with AA After a single dose.
PK analysis set included all participants who received at least 1 dose of both study agents (either as a FDC or SAC) and had at least 1 concentration value. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.
Posted
Mean
Standard Deviation
Nanograms*hour per milliliter (ng*h/mL)
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
ID
Title
Description
OG000
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA
Participants with mCRPC (regardless of HRR BM status) received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as single agent (SA) orally from Cycle 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (Pharmacokinetic [PK] Assessment Phase), Participants had the option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/Dose) of Niraparib Administered With AA After a Single Dose
AUC0(168 hours)/dose was defined as area under the plasma concentration-time curve for niraparib from time 0 to 168 hours of niraparib administered with AA after a single dose.
PK analysis set included all participants who received at least 1 dose of both study agents (either as a FDC or SAC) and had at least 1 concentration value. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.
Posted
Mean
Standard Deviation
nanogram*hour/milliliter/milligram
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
ID
Title
Description
OG000
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA
Participants with mCRPC (regardless of HRR BM status) received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as single agent (SA) orally from Cycle 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (Pharmacokinetic [PK] Assessment Phase), Participants had the option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Combination 1: Parts 1 and 2: Plasma Concentrations of Niraparib
Not Posted
Dec 2026
Day 1
Participants
Secondary
Combination 1: Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Niraparib
Not Posted
Dec 2026
Day 1
Participants
Secondary
Combination 1: Parts 1 and 2: Time to Reach the Maximum Plasma Concentration (Tmax) of Niraparib
Not Posted
Dec 2026
Day 1
Participants
Secondary
Combination 1: Parts 1 and 2: Minimum Observed (Predose) Concentration Following Multiple Dosing (Ctrough) of Niraparib
Not Posted
Dec 2026
Day 1
Participants
Secondary
Combination 1: Parts 1 and 2: Number of Participants With Anti-drug Antibodies of Niraparib
Not Posted
Dec 2026
From baseline up to end of study (6 years 10 months)
Participants
Secondary
Combination 1: Part 2 and Combination 2: Circulating Tumor Cells (CTC) Response
Not Posted
Dec 2026
From baseline up to end of study (6 years 10 months)
Participants
Secondary
Combination 1: Part 2: Composite Response Rate
Not Posted
Dec 2026
From baseline up to end of study (6 years 10 months)
Participants
Secondary
Combination 2: Objective Response Rate (ORR)
Not Posted
Dec 2026
From baseline up to end of study (6 years 10 months)
Participants
Secondary
Combination 1: Part 2 and Combination 2: Duration of Objective Response
Not Posted
Dec 2026
From baseline up to end of study (6 years 10 months)
Participants
Secondary
Combination 1: Part 2 and Combination 2: Overall Survival
Not Posted
Dec 2026
From baseline up to end of study (6 years 10 months)
Participants
Secondary
Combination 3: Cmax of Niraparib and Abiraterone Acetate After a Single Dose For Low-strength FDC
Not Posted
Dec 2026
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Participants
Secondary
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose for Low-strength FDC
Not Posted
Dec 2026
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Participants
Secondary
Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose For Low-strength FDC
Not Posted
Dec 2026
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Participants
Secondary
Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/Dose) of Niraparib Administered With AA After a Single Dose For Low-strength FDC
Not Posted
Dec 2026
Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Participants
Secondary
Combination 3: Number of Participants With Adverse Events
Not Posted
Dec 2026
From baseline up to end of study (6 years 10 months)
Participants
Secondary
Combination 3: Number of Participants With Clinical Laboratory Parameters
Not Posted
Dec 2026
From baseline up to end of study (6 years 10 months)
Participants
Time Frame
Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months
Description
The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and were BM+ received established recommended Phase 2 dose (RP2D) of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and were BM- received established RP2D of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alterations (breast cancer gene [BRCA] biallelic loss [2A]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone (P) 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alterations (BRCA monoallelic loss [2C]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss [2D]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
0
1
1
1
1
1
EG008
Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA
Participants with mCRPC (regardless of HRR BM status) received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as single agent (SA) orally from Cycle 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (Pharmacokinetic [PK] Assessment Phase), Participants had the option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 as fixed-dose combination 1 (FDC1) regular-strength (RS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC2 RS tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Participants with mCRPC received a single oral dose of niraparib 100 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC1 low strength (LS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
2
17
3
17
5
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG0031 affected11 at risk
EG0040 affected8 at risk
EG0052 affected9 at risk
EG0060 affected6 at risk
EG0070 affected1 at risk
EG0082 affected17 at risk
EG0092 affected17 at risk
EG0102 affected17 at risk
EG0110 affected17 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Anal Fistula
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Lower Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Asthenia
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
General Physical Health Deterioration
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Localised Oedema
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Peripheral Swelling
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Pyrexia
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Arthritis Bacterial
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Corona Virus Infection
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Enterocolitis Infectious
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Herpes Simplex Encephalitis
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Pyonephrosis
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Urosepsis
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Lower Limb Fracture
Injury, poisoning and procedural complications
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0020 affected21 at risk
EG003
Diabetic Ketoacidosis
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Tumour Compression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Tumour Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Cerebral Ischaemia
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Presyncope
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Spinal Cord Compression
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Device Dislocation
Product Issues
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Device Occlusion
Product Issues
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Pelvic Pain
Reproductive system and breast disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Pharyngeal Haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Embolism
Vascular disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Pelvic Venous Thrombosis
Vascular disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0003 affected6 at risk
EG0013 affected6 at risk
EG0027 affected21 at risk
EG0034 affected11 at risk
EG0044 affected8 at risk
EG0056 affected9 at risk
EG0062 affected6 at risk
EG0071 affected1 at risk
EG0080 affected17 at risk
EG0091 affected17 at risk
EG0100 affected17 at risk
EG0110 affected17 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0025 affected21 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0025 affected21 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0025 affected21 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0012 affected6 at risk
EG0026 affected21 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Palpitations
Cardiac disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Sinus Tachycardia
Cardiac disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Ear Pain
Ear and labyrinth disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Adrenal Insufficiency
Endocrine disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected21 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Eye Pain
Eye disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Eye Swelling
Eye disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Ocular Hyperaemia
Eye disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0012 affected6 at risk
EG00213 affected21 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0003 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0022 affected21 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Gastrointestinal Angiodysplasia
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Gingival Pain
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Hiatus Hernia
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Lip Dry
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Mouth Ulceration
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0012 affected6 at risk
EG0029 affected21 at risk
EG003
Oral Pain
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Tongue Coated
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0028 affected21 at risk
EG003
Asthenia
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Chest Discomfort
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Chills
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0022 affected21 at risk
EG003
Discomfort
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Fatigue
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0013 affected6 at risk
EG00210 affected21 at risk
EG003
Influenza Like Illness
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Injection Site Swelling
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Malaise
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Oedema Peripheral
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0024 affected21 at risk
EG003
Pain
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Peripheral Swelling
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Pyrexia
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Temperature Intolerance
General disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Candida Infection
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Eye Infection
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Oral Infection
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Tooth Infection
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0022 affected21 at risk
EG003
Urosepsis
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Viral Infection
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Radiation Proctitis
Injury, poisoning and procedural complications
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Skin Abrasion
Injury, poisoning and procedural complications
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0022 affected21 at risk
EG003
Alpha 1 Globulin Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Alpha 2 Globulin Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0023 affected21 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0026 affected21 at risk
EG003
Blood Chloride Decreased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Blood Corticotrophin Decreased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Blood Corticotrophin Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0024 affected21 at risk
EG003
Blood Lactate Dehydrogenase Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Blood Pressure Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected21 at risk
EG003
Blood Thyroid Stimulating Hormone Decreased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Blood Thyroid Stimulating Hormone Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0023 affected21 at risk
EG003
Blood Urea Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Cortisol Decreased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Fibrin D Dimer Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Gamma-Glutamyltransferase Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Lipase Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected21 at risk
EG003
Thyroxine Decreased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Thyroxine Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Tri-Iodothyronine Decreased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0022 affected21 at risk
EG003
Troponin T Increased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Vitamin D Decreased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Weight Decreased
Investigations
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG00210 affected21 at risk
EG003
Abnormal Loss of Weight
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0014 affected6 at risk
EG00213 affected21 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Hyperamylasaemia
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0012 affected6 at risk
EG0024 affected21 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0023 affected21 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0023 affected21 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0024 affected21 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0002 affected6 at risk
EG0011 affected6 at risk
EG0026 affected21 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Foot Deformity
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Joint Swelling
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0023 affected21 at risk
EG003
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0024 affected21 at risk
EG003
Melanocytic Naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Metastases to Bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Tumour Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected21 at risk
EG003
Amnesia
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0012 affected6 at risk
EG0022 affected21 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected21 at risk
EG003
Facial Neuralgia
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0023 affected21 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Mental Impairment
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Migraine
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Peripheral Motor Neuropathy
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0021 affected21 at risk
EG003
Spinal Cord Compression
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Taste Disorder
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Tremor
Nervous system disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0025 affected21 at risk
EG003
Mood Altered
Psychiatric disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Chronic Kidney Disease
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0022 affected21 at risk
EG003
Micturition Urgency
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Renal Impairment
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0024 affected21 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Urinary Tract Obstruction
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Urine Flow Decreased
Renal and urinary disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Pelvic Discomfort
Reproductive system and breast disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Pelvic Pain
Reproductive system and breast disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Testicular Pain
Reproductive system and breast disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0026 affected21 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0023 affected21 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0024 affected21 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0022 affected21 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0023 affected21 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Sinus Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Upper-Airway Cough Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Photosensitivity Reaction
Skin and subcutaneous tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0022 affected21 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0023 affected21 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0022 affected21 at risk
EG003
Skin Burning Sensation
Skin and subcutaneous tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Skin Exfoliation
Skin and subcutaneous tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Skin Hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Skin Lesion
Skin and subcutaneous tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Embolism
Vascular disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Hot Flush
Vascular disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0001 affected6 at risk
EG0011 affected6 at risk
EG0024 affected21 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Orthostatic Hypotension
Vascular disorders
MedDRA Version 22.1
Non-systematic Assessment
EG0000 affected6 at risk
EG0010 affected6 at risk
EG0020 affected21 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 an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Participants with mCRPC and HRR gene alterations (BRCA monoallelic loss [2C]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss [2D]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss [2D]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and were BM- received established RP2D of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alterations (BRCA monoallelic loss [2C]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss [2D]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Units
Counts
Participants
OG0008
OG0019
OG0026
OG0031
Title
Denominators
Categories
Title
Measurements
OG0006
OG0017
OG0024
OG0031
Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 as fixed-dose combination 1 (FDC1) regular-strength (RS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC2 RS tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Units
Counts
Participants
OG00016
OG00116
OG00217
Title
Denominators
Categories
Title
Measurements
OG000428± 189
OG001398± 160
OG002417± 176
Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 as fixed-dose combination 1 (FDC1) regular-strength (RS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC2 RS tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Units
Counts
Participants
OG00016
OG00116
OG00217
Title
Denominators
Categories
Title
Measurements
OG0002.14± 0.95
OG0011.99± 0.80
OG0022.09± 0.88
Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 as fixed-dose combination 1 (FDC1) regular-strength (RS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC2 RS tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Units
Counts
Participants
OG00016
OG00115
OG00217
Title
Denominators
Categories
Title
Measurements
OG00014672± 7346
OG00111862± 4973
OG00213321± 5843
Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 as fixed-dose combination 1 (FDC1) regular-strength (RS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC2 RS tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.