{"analyses":[{"ciLowerLimit":"0.422","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.625","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"<0.0001","pValueComment":"Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies and region.","paramType":"Hazard Ratio (HR)","paramValue":"0.514","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.5","upperLimit":"13.8","value":"11.8"},{"groupId":"OG001","lowerLimit":"5.9","upperLimit":"7.7","value":"6.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"267"},{"groupId":"OG001","value":"262"}],"units":"Participants"}],"description":"Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.","id":"OG000","title":"Sacituzumab Govitecan"},{"description":"Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.\n\nEribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m\\^2 at North American sites and 1.23 mg/m\\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\\^2 and 0.67 mg/m\\^2 for North American and European sites, respectively).\n\nCapecitabine 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 for up to 10.6 months.\n\nGemcitabine 800 to 1200 mg/m\\^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.\n\nVinorelbine 25 mg/m\\^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 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 ITT Population were analyzed.","reportingStatus":"POSTED","timeFrame":"From the randomization to death from any cause (maximum follow-up duration: 30.8 months)","title":"Overall Survival (OS) in ITT Population","type":"SECONDARY","unitOfMeasure":"months"}