{"analyses":[{"ciLowerLimit":"4.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"12.3","groupDescription":"Analysis was based on repeated measures mixed-effect model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate. Analysis was based on restricted maximum likelihood using unstructured covariance matrix.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Mean Difference (Final Values)","paramValue":"8.4","statisticalMethod":"Mixed Models Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.2","upperLimit":"4.8","value":"3.0"},{"groupId":"OG001","lowerLimit":"-8.8","upperLimit":"-2.0","value":"-5.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"262"},{"groupId":"OG001","value":"114"}],"units":"Participants"}],"description":"EORTC QLQ-C30: cancer-specific instrument with 30 questions to assess the participant QoL. First 28 questions used to evaluate 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Each question assessed on 4-point scale (1= not at all, 2= a little, 3= quite a bit, 4= very much); functional scales: higher score = better level of functioning; symptom scale: higher score = more severe symptoms; for single items: higher score= more severe problem. Last 2 questions used to evaluate global health status (GHS)/QoL. Each question was assessed on 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. Change from baseline was calculated by subtracting the baseline value from the average value of Week 4 to 160.","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":"MEAN","populationDescription":"Patient-reported outcomes (PRO) evaluable population included all participants who completed the PRO questionnaire at baseline and at least 1 visit post-baseline.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 4 up to Week 160","title":"Change From Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at Average Duration Over Week 4 up to Week 160","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"units on a scale"}