{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Non-serious AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"31"},{"groupId":"OG003","value":"13"}],"units":"Participants"}],"description":"An AE is any untoward medical occurrence that occurs in a participants or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events. The data is presented for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021","groups":[{"description":"Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 1-Apr-2021 to 26-Dec-2021.","id":"OG000","title":"gBRCA Niraparib (PSU)"},{"description":"Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021","id":"OG001","title":"gBRCA Placebo (PSU)"},{"description":"Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021","id":"OG002","title":"Non-gBRCA Niraparib (PSU)"},{"description":"Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression. This arm presents data for post-study unblinding duration 01-Apr-2021 to 26-Dec-2021","id":"OG003","title":"Non-gBRCA Placebo (PSU)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Population.","reportingStatus":"POSTED","timeFrame":"Up to 8 months, 26 days","title":"Number of Participants With Non-serious AEs and SAEs (Post-study Unblinding)","type":"SECONDARY","unitOfMeasure":"Participants"}