A Study Comparing Niraparib Versus Platinum-Taxane Double... | NCT06964165

ID	Type	Description	Link
2023-505097-16	Registry Identifier	CTIS

Label	Type	Description	Intervention Names
Cohort C (Niraparib)	Experimental		Drug: Niraparib
Cohort C (Carboplatin + Paclitaxel)	Experimental		Drug: Carboplatin Drug: Paclitaxel

Name	Type	Description	Arm Group Labels	Other Names
Niraparib	Drug	Niraparib will be administered	Cohort C (Niraparib)

Measure	Description	Time Frame
Pre-Interval Debulking Surgery (IDS) Unconfirmed Overall Response Rate (ORR)	Pre-IDS unconfirmed ORR is defined as the percentage of participants with unconfirmed complete or partial response on study treatment pre-IDS as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by the Investigator. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters	Up to approximately 102 weeks

Measure	Description	Time Frame
Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria	Serum samples were collected to assess CA-125 progression based on the GCIG CA-125 response criteria, which is defined as follows: Criteria 1 - For participants with elevated CA-125 levels pre-treatment that reduced to the normal range during the study, progression is defined as CA-125 ≥2× Upper limit of normal (ULN) on 2 occasions at least 1 week apart.; Criteria 2 - For participants with elevated CA-125 levels pre-treatment that did not reduce to the normal range during the study, progression is defined as CA-125 ≥2× the nadir value on 2 occasions at least 1 week apart.; Criteria 3 - For participants with CA-125 levels in the normal range pre-treatment, progression is defined as CA-125 ≥2× ULN on 2 occasions at least 1 week apart.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant has newly diagnosed Stage III or IV ovarian, fallopian tube, or primary peritoneal cancer according to the International Federation of Gynecology and Obstetrics staging criteria.
Participants must provide sufficient tumor tissue at Prescreening and agree to undergo a central HRD tumor testing using a fully validated assay. The participants must be HRd as per central HRD tumor testing result for eligibility.
1. Participants with a documented germline breast cancer susceptibility gene (BRCA) 1/2 deleterious or suspected deleterious mutations by Sponsor's permitted test (e.g., BRACAnalysis CDx) may be allowed to enroll prior to receiving the central test results, provided all inclusion criteria are met. However, tumor sample submitted by these participants will still be required for central HRD confirmation. The list of Sponsor's permitted tests will be provided by the Sponsor.
2. All participants must agree to provide tumor tissue collected from IDS.
3. Participant must provide 2 formalin-fixed paraffin-embedded tissue blocks (or slides if blocks are not available) with sufficient tumor content (as confirmed by the Sponsor's designated central and/or testing laboratory) for central HRD testing at Prescreening and for exploratory biomarker testing at Prescreening or Screening. If sufficient tumor tissue is provided at Prescreening, participants do not need to provide additional tissue at Screening.
Participant must have completed 1 run-in cycle of carboplatin-paclitaxel and not experienced disease progression after this treatment. Completion is defined as receiving ≥50% of the prescribed dose of therapy within 5 weeks.
Participant must not have known contraindication or uncontrolled hypersensitivity to carboplatin and paclitaxel and their excipients and no known pre-existing conditions that would preclude treatment with these agents.
Participant must not have known contraindication or uncontrolled hypersensitivity to niraparib and its excipients.
Participant must not have symptomatic ascites or pleural effusions as defined by the following criterion: presence of fluid in the abdominal or pleural cavities requiring removal within 1 week prior to signing the informed consent.
Participant must agree to complete Patient-reported outcome (PRO) and work productivity questionnaires throughout the study.

Exclusion Criteria:

Participant has low-grade or Grade 1 epithelial Ovarian Cancer (OC) or mucinous, germ cell, transitional cell, carcinosarcoma, or undifferentiated tumor.
Participant has contraindications to surgery.
Participant has a bowel obstruction by clinical symptoms or Computed tomography (CT) scan, subocclusive mesenteric disease, abdominal or gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess.
Participant has any known history or current diagnosis of Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML).
Participant is at increased bleeding risk due to concurrent conditions (e.g., major injuries or major surgery within the past 28 days prior to the start of study treatment and/or history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).
Participant is immunocompromised. Participants with splenectomy are allowed. Participants with known Human immunodeficiency virus (HIV) are allowed if they meet all of the following criteria:
1. Cluster of differentiation 4-positive T cell count ≥350/μL and viral load <400 copies/mL
2. No history of Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to enrollment
3. No history of HIV-associated malignancy for the past 5 years
4. Concurrent antiretroviral therapy as per the most current National Institutes of Health Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV started >4 weeks prior to study enrollment
Participant received prior treatment for high-grade non-mucinous epithelial ovarian, fallopian tube, or peritoneal cancer (e.g., prior surgery, immunotherapy, anticancer therapy [with the exception of 1 run-in cycle of carboplatin-paclitaxel], or radiation therapy).
Participant has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic therapy (e.g., thyroid hormone or insulin).
Participant is unable to swallow orally administered medication or has a gastrointestinal disorder likely to interfere with absorption of the study medication.
Participant received whole blood transfusions in the 2 weeks prior to entry to the study (packed red blood cells and platelet transfusions are acceptable outside of 2 weeks prior to treatment).

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		San Francisco	California	94115	United States
GSK Investigational Site

ID	Title	Description
FG000	Platinum-taxane	Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 31, 2023	Jun 25, 2025

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

Pre-Interval Debulking Surgery (IDS) Unconfirmed Overall Response Rate (ORR)

Pre-IDS unconfirmed ORR is defined as the percentage of participants with unconfirmed complete or partial response on study treatment pre-IDS as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by the Investigator. Complete Response (CR) is defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. Partial Response (PR) is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters

Intent-to-Treat population included all randomized participants whether or not randomized treatment was administered.

Posted

Number

95% Confidence Interval

Percentage of Participants

Up to approximately 102 weeks

ID	Title	Description
OG000	Platinum-taxane	Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
OG001	Niraparib	Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.

Units	Counts
Participants	OG00017 OG00119

Title

Denominators

Categories

Title	Measurements
	OG00070.6(44.04 to 89.69) OG00131.6(16.34 to 67.71)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Difference in pre-IDS ORR	-39			2-Sided	80	-56.8	-17.7					Other

Secondary

Number of Participants With Cancer Antigen (CA)-125 Progression by Gynecological Cancer InterGroup (GCIG) CA-125 Response Criteria

Serum samples were collected to assess CA-125 progression based on the GCIG CA-125 response criteria, which is defined as follows: Criteria 1 - For participants with elevated CA-125 levels pre-treatment that reduced to the normal range during the study, progression is defined as CA-125 ≥2× Upper limit of normal (ULN) on 2 occasions at least 1 week apart.; Criteria 2 - For participants with elevated CA-125 levels pre-treatment that did not reduce to the normal range during the study, progression is defined as CA-125 ≥2× the nadir value on 2 occasions at least 1 week apart.; Criteria 3 - For participants with CA-125 levels in the normal range pre-treatment, progression is defined as CA-125 ≥2× ULN on 2 occasions at least 1 week apart.

Intent-to-Treat population

Posted

Count of Participants

Participants

At week 24

ID	Title	Description
OG000	Platinum-taxane	Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
OG001

Secondary

Progression Free Survival (PFS)

PFS is defined as the time from the date of treatment randomization to the date of first documentation of disease progression (PD) per RECIST v1.1 or death by any cause, whichever occurs first, as determined by the Investigator. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g. percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5mm.

As pre-specified in Section 2 of the Statistical Analysis Plan, analyses was not performed due to low maturity (<30%) for PFS data, resulting from insufficient number of participants with events within the length of follow-up in assessing the number of events.

Posted

Up to approximately 154 weeks

ID	Title	Description
OG000	Platinum-taxane	Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
OG001

Secondary

Overall Survival (OS)

OS is defined as the time from the date of treatment randomization to the date of death by any cause.

As pre-specified in Section 2 of the Statistical Analysis Plan, analyses was not performed due to low maturity (<30%) for OS data, resulting from insufficient number of participants with events within the length of follow-up in assessing the number of events.

Posted

Up to approximately 154 weeks

ID	Title	Description
OG000	Platinum-taxane	Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
OG001	Niraparib	Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.

Secondary

Time to First Subsequent Treatment (TFST)

TFST is defined as the time from the date of treatment randomization to the date of first subsequent anticancer therapy or death.

As pre-specified in Section 2 of the Statistical Analysis Plan, analyses was not performed due to low maturity (<30%) for TFST data, resulting from insufficient number of participants with events within the length of follow-up in assessing the number of events.

Posted

Up to approximately 154 weeks

ID	Title	Description
OG000	Platinum-taxane	Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
OG001	Niraparib	Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.

Secondary

Number of Participants With Frequency and Severity of Items as Measured by Patient Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

The PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants of cancer clinical studies. It characterizes the frequency and severity of adverse events using a standardized scoring system. Responses include 0 ("never" OR "none" OR "Not at all"); 1 ("Rarely" OR "Mild" OR "A little bit"); 2 ("Occasionally" OR "Moderate" OR "Somewhat"); 3 ("Frequently" OR "Severe" OR "Quite a bit") and 4 ("almost constantly" OR "very severe" OR "Very much"), with a higher score indicating a higher frequency and severity of adverse events.

Intent to Treat Population is included as the Overall Number of Participants Analyzed. 'Number Analyzed' refers to participants evaluable at the specified time points. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.

Posted

Count of Participants

Participants

Baseline (Predose), Day 8 and 15 of Cycle 1; Day 1, 8 and 15 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks).

ID	Title	Description
OG000	Platinum-taxane	Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.

Secondary

Number of Participants With Overall Side Effect Bother as Measured by Functional Assessment of Cancer Therapy - Item FACT-GP5

The FACT-GP5 item is a single item from the FACT-G that assesses how bothersome the side effects of treatment are for participants with cancer. It evaluates the extent to which side effects of treatment are bothersome for cancer participants. This outcome is measured using a 5-category response scale, where responses include 0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," and 4="Very much." A higher score on this measure indicates that the participant experiences a greater level of bother from the side effects of treatment.

Posted

Count of Participants

Participants

Baseline (Predose), Day 8 and 15 of Cycle 1; Day 1, 8, and 15 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks)

ID	Title	Description
OG000	Platinum-taxane	Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.

Secondary

Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 136 (EORTC IL136) Questionnaire

EORTC IL136 includes items from the EORTC QLQ-C30, a 30-item survey assessing health-related quality of life (HRQoL) in cancer patients, featuring 5 functional scales, 3 symptom scales, 6 single items, and a global health status/HRQoL scale. Functional and symptom scales/items are rated on 4-point scale with options "Not at all," "A little," "Quite a bit," and "Very much". 2 items measuring global health status/quality of life use a 7-point scale ranging from 1 ("Very Poor") to 7 ("Excellent"). Each item has a specific scoring system, and scores were transformed to a 0-100 scale, where higher scores on functional scales and global health status/HRQoL scale indicate better functioning or quality of life, while higher scores on symptom scales/items indicate greater symptom burden. Baseline is defined as the latest assessment with a non-missing value prior to Cycle 1 Day 1 (C1D1), including those from unscheduled visits.

Posted

Mean

Standard Deviation

Scores on scale

Baseline (Predose), Day 1 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks).

ID	Title	Description
OG000	Platinum-taxane	Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.

Secondary

Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Item Library 137 (EORTC IL137) Questionnaire

The OC module (QLQ-OV28) supplements the QLQ-C30 and was designed for participants with local or advanced disease who receive treatment by surgery with or without chemotherapy. It consists of 28 items including 3 functional scales (body image, sexuality, attitude to disease/treatment burden) and 5 symptom scales/items (abdominal/gastrointestinal symptoms, peripheral neuropathy, hormonal/menopausal symptoms, other chemotherapy side effects, and hair loss). A subset of 9 questions will be utilized for this cohort, referred to as the EORTC IL137. The scoring approach is identical to the EORTC QLQ-C30. Scores are transformed to a 0-100 scale, where higher functional scale scores indicate better functioning, and higher symptom scale scores indicate greater symptom burden. Baseline is defined as the latest assessment with a non-missing value prior to C1D1, including unscheduled visits.

Posted

Mean

Standard Deviation

Scores on scale

Baseline (Predose), Day 1 of Cycle 2 and Cycle 3; Pre-IDS Evaluation, and End of Treatment (Up to approximately 154 weeks).

ID	Title	Description
OG000	Platinum-taxane	Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.

Secondary

Number of Participants With Treatment Emergent (TE) Non-serious Adverse Events (Non-SAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Treatment Emergent (TE) Special Interest (AESIs) by Severity

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subsets of AEs. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Safety population included all randomized participants who received at least one dose of study treatment.

Posted

Count of Participants

Participants

Up to approximately 154 weeks

ID	Title	Description
OG000	Platinum-taxane	Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.

Secondary

Number of Participants With Dose Modification Due to TEAEs

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state. Number of participants with dose modifications : permanent discontinuation, dose reduction and treatment interruption/delay due to AEs is summarized.

Safety population

Posted

Count of Participants

Participants

Up to approximately 154 weeks

ID	Title	Description
OG000	Platinum-taxane	Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
OG001	Niraparib	Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v28.0	Systematic Assessment	EG00040 events11 affected17 at risk EG00124 events10 affected19 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA v28.0	Systematic Assessment	EG0005 events1 affected17 at risk EG0010 events0 affected19 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v28.0	Systematic Assessment	EG00016 events8 affected17 at risk EG0019 events3 affected19 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v28.0	Systematic Assessment	EG00020 events8 affected17 at risk EG00113 events5 affected19 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Cardiac failure	Cardiac disorders	MedDRA v28.0	Systematic Assessment	EG0004 events1 affected17 at risk EG0010 events0 affected19 at risk
Palpitations	Cardiac disorders	MedDRA v28.0	Systematic Assessment	EG0004 events3 affected17 at risk EG0011 events1 affected19 at risk
Tachycardia	Cardiac disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected19 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA v28.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0011 events1 affected19 at risk
Vertigo	Ear and labyrinth disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Hypothyroidism	Endocrine disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Thyroiditis	Endocrine disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Cataract	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Diplopia	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Eczema eyelids	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Eye swelling	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Narrow anterior chamber angle	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Vision blurred	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected19 at risk
Vitreous floaters	Eye disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0013 events3 affected19 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected19 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG00016 events8 affected17 at risk EG0019 events6 affected19 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected19 at risk
Abdominal wall pain	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Anal fissure	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Ascites	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Colitis	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Constipation	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG00014 events10 affected17 at risk EG00113 events8 affected19 at risk
Dental caries	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected19 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0009 events5 affected17 at risk EG0014 events3 affected19 at risk
Dry mouth	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected19 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0011 events1 affected19 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Eructation	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Flatulence	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0011 events1 affected19 at risk
Food poisoning	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0007 events5 affected17 at risk EG0010 events0 affected19 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0005 events3 affected17 at risk EG0011 events1 affected19 at risk
Intra-abdominal fluid collection	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected19 at risk
Nausea	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG00025 events11 affected17 at risk EG0015 events4 affected19 at risk
Peritoneal haematoma	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0004 events2 affected17 at risk EG0010 events0 affected19 at risk
Stomatitis	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0013 events2 affected19 at risk
Vomiting	Gastrointestinal disorders	MedDRA v28.0	Systematic Assessment	EG00014 events8 affected17 at risk EG0017 events4 affected19 at risk
Asthenia	General disorders	MedDRA v28.0	Systematic Assessment	EG00010 events4 affected17 at risk EG0016 events4 affected19 at risk
Early satiety	General disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Fatigue	General disorders	MedDRA v28.0	Systematic Assessment	EG00046 events14 affected17 at risk EG00112 events7 affected19 at risk
General physical health deterioration	General disorders	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected19 at risk
Generalised oedema	General disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Influenza like illness	General disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0014 events3 affected19 at risk
Mucosal inflammation	General disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Non-cardiac chest pain	General disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Oedema	General disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Oedema peripheral	General disorders	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0011 events1 affected19 at risk
Pain	General disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Pyrexia	General disorders	MedDRA v28.0	Systematic Assessment	EG0005 events3 affected17 at risk EG0011 events1 affected19 at risk
Hypertransaminasaemia	Hepatobiliary disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Contrast media allergy	Immune system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events1 affected19 at risk
Drug hypersensitivity	Immune system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Bacterial vaginosis	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
COVID-19	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0011 events1 affected19 at risk
Cellulitis	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Ear infection	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Folliculitis	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected19 at risk
Gastroenteritis	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Herpes ophthalmic	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Nasopharyngitis	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0009 events6 affected17 at risk EG0011 events1 affected19 at risk
Oral candidiasis	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Oral herpes	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Otitis externa	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Peritonitis	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Postoperative abscess	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Rash pustular	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Sinusitis	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected19 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Urinary tract infection	Infections and infestations	MedDRA v28.0	Systematic Assessment	EG0004 events4 affected17 at risk EG0011 events1 affected19 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0004 events3 affected17 at risk EG0010 events0 affected19 at risk
Gastrointestinal procedural complication	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected19 at risk
Post procedural constipation	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected19 at risk
Postoperative adhesion	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events1 affected19 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0013 events3 affected19 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0003 events2 affected17 at risk EG0015 events3 affected19 at risk
Procedural vomiting	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected19 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Alanine aminotransferase increased	Investigations	MedDRA v28.0	Systematic Assessment	EG0004 events2 affected17 at risk EG0011 events1 affected19 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v28.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0011 events1 affected19 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected19 at risk
Blood creatinine increased	Investigations	MedDRA v28.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0012 events2 affected19 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Blood pressure increased	Investigations	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Brain natriuretic peptide increased	Investigations	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Neutrophil count decreased	Investigations	MedDRA v28.0	Systematic Assessment	EG00017 events6 affected17 at risk EG0018 events4 affected19 at risk
Oxygen saturation decreased	Investigations	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected19 at risk
Platelet count decreased	Investigations	MedDRA v28.0	Systematic Assessment	EG00010 events6 affected17 at risk EG0013 events1 affected19 at risk
Weight decreased	Investigations	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0011 events1 affected19 at risk
Weight increased	Investigations	MedDRA v28.0	Systematic Assessment	EG0008 events4 affected17 at risk EG0012 events1 affected19 at risk
White blood cell count decreased	Investigations	MedDRA v28.0	Systematic Assessment	EG0005 events2 affected17 at risk EG0013 events2 affected19 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG00011 events6 affected17 at risk EG0014 events4 affected19 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0006 events4 affected17 at risk EG0011 events1 affected19 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0005 events4 affected17 at risk EG0014 events3 affected19 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG00011 events5 affected17 at risk EG0019 events3 affected19 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0011 events1 affected19 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0011 events1 affected19 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0003 events2 affected17 at risk EG0010 events0 affected19 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected19 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG00011 events7 affected17 at risk EG0014 events3 affected19 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0006 events5 affected17 at risk EG0010 events0 affected19 at risk
Temporomandibular pain and dysfunction syndrome	Musculoskeletal and connective tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Amnesia	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Aphasia	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Disturbance in attention	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0010 events0 affected19 at risk
Dizziness	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0009 events6 affected17 at risk EG0011 events1 affected19 at risk
Dysaesthesia	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Dysgeusia	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0013 events3 affected19 at risk
Headache	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG00018 events7 affected17 at risk EG0015 events4 affected19 at risk
Hyperaesthesia	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Hypoaesthesia	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected19 at risk
Memory impairment	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected19 at risk
Neuralgia	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG00034 events13 affected17 at risk EG0011 events1 affected19 at risk
Paraesthesia	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0009 events4 affected17 at risk EG0011 events1 affected19 at risk
Peripheral motor neuropathy	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected19 at risk
Restless legs syndrome	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected19 at risk
Sciatica	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Speech disorder	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Tremor	Nervous system disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Umbilical granuloma	Pregnancy, puerperium and perinatal conditions	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Abnormal dreams	Psychiatric disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Anxiety	Psychiatric disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0012 events2 affected19 at risk
Insomnia	Psychiatric disorders	MedDRA v28.0	Systematic Assessment	EG00011 events8 affected17 at risk EG0019 events9 affected19 at risk
Dysuria	Renal and urinary disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Haematuria	Renal and urinary disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Micturition urgency	Renal and urinary disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Pollakiuria	Renal and urinary disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Renal failure	Renal and urinary disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Urinary retention	Renal and urinary disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Breast haematoma	Reproductive system and breast disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Breast mass	Reproductive system and breast disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Breast tenderness	Reproductive system and breast disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Dyspareunia	Reproductive system and breast disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected19 at risk
Pelvic haematoma	Reproductive system and breast disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected19 at risk
Vaginal haematoma	Reproductive system and breast disorders	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected19 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA v28.0	Systematic Assessment	EG0004 events3 affected17 at risk EG0010 events0 affected19 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0011 events1 affected19 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0007 events4 affected17 at risk EG0016 events4 affected19 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected19 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0010 events0 affected19 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected19 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0004 events1 affected17 at risk EG0010 events0 affected19 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events1 affected19 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG00012 events8 affected17 at risk EG0013 events3 affected19 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0012 events2 affected19 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0004 events2 affected17 at risk EG0010 events0 affected19 at risk
Excessive granulation tissue	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Hair growth abnormal	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Nail bed bleeding	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Onycholysis	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected19 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected19 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG00011 events5 affected17 at risk EG0010 events0 affected19 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG00017 events7 affected17 at risk EG0014 events3 affected19 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Sensitive skin	Skin and subcutaneous tissue disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Deep vein thrombosis	Vascular disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events1 affected19 at risk
Haematoma	Vascular disorders	MedDRA v28.0	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected19 at risk
Hot flush	Vascular disorders	MedDRA v28.0	Systematic Assessment	EG0003 events3 affected17 at risk EG0014 events4 affected19 at risk
Hypertension	Vascular disorders	MedDRA v28.0	Systematic Assessment	EG0008 events5 affected17 at risk EG00111 events6 affected19 at risk
Hypotension	Vascular disorders	MedDRA v28.0	Systematic Assessment	EG0005 events2 affected17 at risk EG0011 events1 affected19 at risk
Varicose vein	Vascular disorders	MedDRA v28.0	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected19 at risk

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D000091662	Genital Diseases
D004700	Endocrine System Diseases
D006058	Gonadal Disorders

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D004224	Diterpenes
D013729	Terpenes

ID	Title	Description
BG000	Platinum-taxane	Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.
BG001	Niraparib	Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Platinum-taxane	Participants with ovarian cancer received platinum-taxane doublet chemotherapy as solution for intravenous infusion for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent interval debulking surgery (IDS) with recovery period of up to 6 weeks. After IDS, all participants received another three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional followed by niraparib maintenance treatment for up to 36 months or until an adverse event (AE), progression of disease (PD) per RECIST v1.1.	4	17	4	17	17	17
EG001	Niraparib	Participants with ovarian cancer received 100 milligram (mg) Niraparib capsules orally for three 21-day cycles (Cycles 1, 2 and 3). After 3 cycles of treatment, the participants underwent IDS with recovery period of up to 6 weeks. After IDS, all participants received three 21-day cycles of platinum-taxane doublet chemotherapy (Cycles 4, 5, and 6), with the last cycle (Cycle 6) being optional, followed by niraparib maintenance treatment for up to 36 months or until an AE, PD per RECIST v1.1. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelets count ≥ 150000 cells per microliter were administered 300 mg of Niraparib. Participants with screening actual body weight less than 77 kg or screening platelets count less than 150000 cells per microliter were administered 200 mg of niraparib.	4	19	2	19	19	19