{"analyses":[{"ciLowerLimit":"0.198","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.775","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).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0053","paramType":"Hazard Ratio (HR)","paramValue":"0.392","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Median and 95% CI was not estimable due to the low number of participants with event.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Median and upper limit of 95% CI was not estimable due to the low number of participants with event.","groupId":"OG001","lowerLimit":"10.3","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"114"}],"units":"Participants"}],"description":"TTD was defined as the time (in months) from randomization to the first observation with a\\>=10 point increase and no subsequent observations with a \\<10 point increase from baseline in breast symptom score based on the EORTC-QLQ-BR23. EORTC-QLQ-BR23 is a disease-specific module for breast cancer developed as a supplement for the EORTC-QLQ-C30 to assess the quality of life of participants with breast cancer. EORTC-QLQ-BR23 symptoms subscale includes 4 items: systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss. Each item is rated by choosing 1 of 4 possible responses that record the level of intensity (1= not at all, 2= a little, 3= quite a bit, and 4= very much), higher scores=high level of symptom/problems.","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 Breast Symptoms Scale as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC-QLQ-BR23)","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"months"}