{"analyses":[{"ciLowerLimit":"0.257","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.549","groupDescription":"Hazard ratio is based on stratified Cox regression model with treatment as the only covariate (stratification factors: number of prior cytotoxic chemotherapy regimens, triple negative status, history of central nervous system metastasis status).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.376","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Upper limit of 95% CI was not estimable, since only few participants had event.","groupId":"OG000","lowerLimit":"13.8","upperLimit":"NA","value":"24.3"},{"groupId":"OG001","lowerLimit":"4.9","upperLimit":"12.2","value":"6.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"114"}],"units":"Participants"}],"description":"TTD in global health status (GHS)/QoL=time (in months) from randomization to the first observation with \\>=10 point decrease and no subsequent observations with\\<10 point decrease from baseline in GHS/QoL score based on EORTC-QLQ-C30. EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to assess participant quality of life. Question 29 and 30 were used to evaluate GHS/QoL. Each question was assessed on a 7-point scale (1=very poor to 7=excellent). Scores averaged, transformed to 0-100 scale; higher score=better quality of life/better level of functioning.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received talazoparib 1 mg, orally, once daily until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or sponsor's decision to terminate the trial (up to a maximum of 70.2 months). One cycle was of 21 days.","id":"OG000","title":"Talazoparib"},{"description":"Participants received 1 of the following drugs in specified regimens, as per the physician's choice: 1) capecitabine 1250 mg/m\\^2 orally twice daily on Day 1 to 14 in each cycle; 2) eribulin mesylate 1.4 mg/m\\^2 (equivalent to eribulin 1.23 mg/ m\\^2), as 2 to 5 minute IV infusion on Day 1 and 8 in each cycle; 3) gemcitabine 1250 mg/m\\^2 as 30-minute IV infusion on Day 1 and 8 in each cycle; 4) vinorelbine 30 mg/m\\^2 as 6 to 10 minute IV infusion on Day 1, 8, and 15 in each cycle; until radiographic disease progression as determined by the central IRF, unacceptable toxicity, consent withdrawal, physician's decision to terminate treatment, or Sponsor's decision to terminate the trial (up to a maximum of 45.3 months). One cycle was of 21 days.","id":"OG001","title":"Physician's Choice Treatment"}],"paramType":"MEDIAN","populationDescription":"PRO-evaluable population included all participants who completed the PRO questionnaire at baseline and at least 1 visit post-baseline.","reportingStatus":"POSTED","timeFrame":"Baseline up to a maximum duration of 36.9 months","title":"Time to Deterioration (TTD) in Global Health Status/Quality of Life (QOL)","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"months"}