{"denoms":[{"counts":[{"groupId":"BG000","value":"375"},{"groupId":"BG001","value":"383"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"1140"}],"units":"Participants"}],"groups":[{"description":"Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \\[AUC\\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.\n\nParticipants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.","id":"BG000","title":"Placebo + Carboplatin + Paclitaxel -> Placebo"},{"description":"Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.\n\nParticipants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.","id":"BG001","title":"Veliparib + Carboplatin + Paclitaxel -> Placebo"},{"description":"Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles.\n\nParticipants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.","id":"BG002","title":"Veliparib + Carboplatin + Paclitaxel -> Veliparib"},{"description":"Total of all reporting groups","id":"BG003","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"33.0","upperLimit":"86.0","value":"62.0"},{"groupId":"BG001","lowerLimit":"22.0","upperLimit":"88.0","value":"62.0"},{"groupId":"BG002","lowerLimit":"30.0","upperLimit":"85.0","value":"62.0"},{"groupId":"BG003","lowerLimit":"22.0","upperLimit":"88.0","value":"62.0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"375"},{"groupId":"BG001","value":"383"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"1140"}],"units":"Participants"}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"233"},{"groupId":"BG001","value":"226"},{"groupId":"BG002","value":"228"},{"groupId":"BG003","value":"687"}],"title":"< 65 years"},{"measurements":[{"groupId":"BG000","value":"142"},{"groupId":"BG001","value":"157"},{"groupId":"BG002","value":"154"},{"groupId":"BG003","value":"453"}],"title":"≥ 65 years"}],"denoms":[{"counts":[{"groupId":"BG000","value":"375"},{"groupId":"BG001","value":"383"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"1140"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"375"},{"groupId":"BG001","value":"383"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"1140"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}],"title":"Male"}],"denoms":[{"counts":[{"groupId":"BG000","value":"375"},{"groupId":"BG001","value":"383"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"1140"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"26"},{"groupId":"BG003","value":"81"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"347"},{"groupId":"BG001","value":"356"},{"groupId":"BG002","value":"356"},{"groupId":"BG003","value":"1059"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}],"title":"Unknown or Not Reported"}],"denoms":[{"counts":[{"groupId":"BG000","value":"375"},{"groupId":"BG001","value":"383"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"1140"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"299"},{"groupId":"BG001","value":"297"},{"groupId":"BG002","value":"300"},{"groupId":"BG003","value":"896"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"20"},{"groupId":"BG003","value":"43"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"59"},{"groupId":"BG001","value":"69"},{"groupId":"BG002","value":"56"},{"groupId":"BG003","value":"184"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"3"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"3"}],"title":"Native Hawaiian or other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"3"}],"title":"Multi-race"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"8"}],"title":"Missing"}],"denoms":[{"counts":[{"groupId":"BG000","value":"375"},{"groupId":"BG001","value":"383"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"1140"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"266"},{"groupId":"BG001","value":"261"},{"groupId":"BG002","value":"267"},{"groupId":"BG003","value":"794"}],"title":"North America"},{"measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"78"}],"title":"Japan"},{"measurements":[{"groupId":"BG000","value":"86"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"90"},{"groupId":"BG003","value":"268"}],"title":"Rest of World"}],"denoms":[{"counts":[{"groupId":"BG000","value":"375"},{"groupId":"BG001","value":"383"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"1140"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Geographic Region","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"98"},{"groupId":"BG002","value":"108"},{"groupId":"BG003","value":"298"}],"title":"Germline or tissue BRCA1/2 mutation"},{"measurements":[{"groupId":"BG000","value":"254"},{"groupId":"BG001","value":"243"},{"groupId":"BG002","value":"245"},{"groupId":"BG003","value":"742"}],"title":"Germline or tissue BRCA1/2 wildtype"},{"measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"29"},{"groupId":"BG003","value":"100"}],"title":"Missing"}],"denoms":[{"counts":[{"groupId":"BG000","value":"375"},{"groupId":"BG001","value":"383"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"1140"}],"units":"Participants"}]}],"description":"The BRCA-mutation cohort was defined as participants who had deleterious or suspected deleterious germline (gBRCA) or tissue-based (tBRCA) mutations as determined by the Myriad BRACAnalysis® companion diagnostic (CDx) or myChoice® HRD CDx assay, respectively, in BRCA1 or BRCA2.","paramType":"COUNT_OF_PARTICIPANTS","title":"BRCA-Deficient Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"207"},{"groupId":"BG001","value":"206"},{"groupId":"BG002","value":"214"},{"groupId":"BG003","value":"627"}],"title":"HRD"},{"measurements":[{"groupId":"BG000","value":"124"},{"groupId":"BG001","value":"123"},{"groupId":"BG002","value":"125"},{"groupId":"BG003","value":"372"}],"title":"Non-HRD"},{"measurements":[{"groupId":"BG000","value":"44"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"141"}],"title":"Missing"}],"denoms":[{"counts":[{"groupId":"BG000","value":"375"},{"groupId":"BG001","value":"383"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"1140"}],"units":"Participants"}]}],"description":"The HRD cohort consisted of participants who had tumors that were BRCA-mutated or had HRD according to the Myriad myChoice® assay, on which a score of ≥ 33 was considered to indicate HRD status, and a score of \\< 33 was considered to indicate non-HRD status.","paramType":"COUNT_OF_PARTICIPANTS","title":"Homologous Recombination Deficiency (HRD) Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"292"},{"groupId":"BG001","value":"288"},{"groupId":"BG002","value":"295"},{"groupId":"BG003","value":"875"}],"title":"Stage III"},{"measurements":[{"groupId":"BG000","value":"82"},{"groupId":"BG001","value":"94"},{"groupId":"BG002","value":"87"},{"groupId":"BG003","value":"263"}],"title":"Stage IV"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}],"title":"Missing"}],"denoms":[{"counts":[{"groupId":"BG000","value":"375"},{"groupId":"BG001","value":"383"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"1140"}],"units":"Participants"}]}],"description":"Staging of primary ovarian carcinomas according to the International Federation of Gynecology and Obstetrics (FIGO) criteria, based on clinical examination, surgical exploration, histologic characteristics and cytologic testing.\n\nSTAGE III: Tumor involves 1 or both ovaries with cytologically or histologically confirmed spread to the peritoneum outside the pelvis and/or metastases to the retroperitoneal lymph nodes.\n\nSTAGE IV: Distant metastases excluding peritoneal metastases","paramType":"COUNT_OF_PARTICIPANTS","title":"Stage of Disease","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"250"},{"groupId":"BG001","value":"253"},{"groupId":"BG002","value":"261"},{"groupId":"BG003","value":"764"}],"title":"Primary"},{"measurements":[{"groupId":"BG000","value":"107"},{"groupId":"BG001","value":"114"},{"groupId":"BG002","value":"99"},{"groupId":"BG003","value":"320"}],"title":"Interval"},{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"56"}],"title":"No surgery received"}],"denoms":[{"counts":[{"groupId":"BG000","value":"375"},{"groupId":"BG001","value":"383"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"1140"}],"units":"Participants"}]}],"description":"Cytoreductive surgery could be performed before randomization and the initiation of study treatment (primary) or after 3 cycles of study treatment (interval), determined at the discretion of the investigator.","paramType":"COUNT_OF_PARTICIPANTS","title":"Type of Surgery Received","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"116"},{"groupId":"BG001","value":"118"},{"groupId":"BG002","value":"124"},{"groupId":"BG003","value":"358"}],"title":"No residual disease"},{"measurements":[{"groupId":"BG000","value":"58"},{"groupId":"BG001","value":"46"},{"groupId":"BG002","value":"54"},{"groupId":"BG003","value":"158"}],"title":"Microscopic residual disease only"},{"measurements":[{"groupId":"BG000","value":"76"},{"groupId":"BG001","value":"89"},{"groupId":"BG002","value":"83"},{"groupId":"BG003","value":"248"}],"title":"Any macroscopic residual disease"}],"denoms":[{"counts":[{"groupId":"BG000","value":"250"},{"groupId":"BG001","value":"253"},{"groupId":"BG002","value":"261"},{"groupId":"BG003","value":"764"}],"units":"Participants"}]}],"description":"Data were collected after interval surgery after cycle 3.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Participants who underwent primary surgery","title":"Residual Disease After Primary Surgery","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"46"},{"groupId":"BG002","value":"45"},{"groupId":"BG003","value":"141"}],"title":"No residual disease"},{"measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"24"},{"groupId":"BG003","value":"76"}],"title":"Microscopic residual disease only"},{"measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"34"},{"groupId":"BG002","value":"27"},{"groupId":"BG003","value":"92"}],"title":"Any macroscopic residual disease"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"11"}],"title":"Missing"}],"denoms":[{"counts":[{"groupId":"BG000","value":"107"},{"groupId":"BG001","value":"114"},{"groupId":"BG002","value":"99"},{"groupId":"BG003","value":"320"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Participants who underwent interval surgery","title":"Residual Disease After Interval Surgery","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"193"},{"groupId":"BG001","value":"203"},{"groupId":"BG002","value":"190"},{"groupId":"BG003","value":"586"}],"title":"Weekly"},{"measurements":[{"groupId":"BG000","value":"179"},{"groupId":"BG001","value":"178"},{"groupId":"BG002","value":"189"},{"groupId":"BG003","value":"546"}],"title":"Every 3 weeks"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"8"}],"title":"Missing"}],"denoms":[{"counts":[{"groupId":"BG000","value":"375"},{"groupId":"BG001","value":"383"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"1140"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Paclitaxel Dosing Regimen","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"63"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"80"},{"groupId":"BG003","value":"214"}],"title":"Germline BRCA1/2 mutation"},{"measurements":[{"groupId":"BG000","value":"305"},{"groupId":"BG001","value":"305"},{"groupId":"BG002","value":"298"},{"groupId":"BG003","value":"908"}],"title":"Germline BRCA1/2 wildtype"},{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"18"}],"title":"Missing"}],"denoms":[{"counts":[{"groupId":"BG000","value":"375"},{"groupId":"BG001","value":"383"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"1140"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Germline BRCA Status","unitOfMeasure":"Participants"}],"populationDescription":"The intention-to-treat (ITT) population consisted of all randomized participants."}