{"analyses":[{"ciLowerLimit":"0.598","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.894","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0021","pValueComment":"Stratified log-rank test and stratified Cox regression adjusted for stratification factors: prior chemotherapy regimens for metastatic disease, presence of visceral metastasis, and endocrine therapy in the metastatic setting for at least 6 months.","paramType":"Hazard Ratio (HR)","paramValue":"0.732","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.6","upperLimit":"2.8","value":"2.2"},{"groupId":"OG001","lowerLimit":"1.1","upperLimit":"1.9","value":"1.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"234"},{"groupId":"OG001","value":"205"}],"units":"Participants"}],"description":"TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the fatigue score.The EORTC QLQ-C30 is a questionnaire to assess quality of life, it is composed of 30 questions(items) resulting in 5 functional scales(physical, role, emotional, cognitive, social),1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties).All of the scales and single-item measures range in score from 0 to 100.Participant responses to 3 questions about fatigue 'Did you need to rest', 'Have you felt weak' and 'Were you tired' were scored on a 4-point scale (1=not at all;4=very much).Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100. Higher scores on the symptom scales indicate a higher level of symptoms (i.e. a worse state of the participant).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion on Days 1 and 8 of a 21-day treatment cycle until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met (up to 40.1 months).","id":"OG000","title":"Sacituzumab Govitecan"},{"description":"Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent treatment that was determined by the investigator before participant randomization until progression of disease, occurrence of unacceptable AEs, or another treatment discontinuation criterion was met. Dosing per NCCN guidelines (with dose modifications for if toxic)\n\n* Eribulin was administered IV at a dose 1.4 mg/m\\^2 at North American sites and 1.2 mg/m\\^2 at European sites on Days 1 and 8 of a 21-day cycle (up to 22.5 months).\n* Capecitabine 1000 to 1250 mg/m\\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period (up to 12.9 months).\n* Gemcitabine 800 to 1200 mg/m\\^2 was administered IV on Days 1, 8, and 15 of a 28-day cycle (up to 22.3 months).\n* Vinorelbine 25 mg/m\\^2 was administered as a weekly IV injection (up to 8.1 months). Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.","id":"OG001","title":"Treatment of Physician's Choice (TPC)"}],"paramType":"MEDIAN","populationDescription":"Participants in the HRQOL-Evaluable Population with baseline fatigue score ≤ 90 were analyzed.","reportingStatus":"POSTED","timeFrame":"Up to 37.8 months","title":"TTD of Fatigue Score as Measured by EORTC QLQ-C30","type":"SECONDARY","unitOfMeasure":"months"}