{"analyses":[{"ciLowerLimit":"0.150","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.107","groupDescription":"DOR by IRC Assessment","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0683","pValueComment":"Stratified log-rank test and stratified Cox regression adjusted for stratification factors: number of prior chemotherapies, and region.","paramType":"Hazard Ratio (HR)","paramValue":"0.407","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.103","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.435","groupDescription":"DOR by Investigator Assessment","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":"0.212","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.5","upperLimit":"7.9","value":"6.3"},{"comment":"Due to smaller number of participants with an event, upper limit of 95% confidence interval (CI) could not be calculated.","groupId":"OG001","lowerLimit":"2.8","upperLimit":"NA","value":"3.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"82"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"IRC Assessment"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.6","upperLimit":"7.9","value":"6.9"},{"groupId":"OG001","lowerLimit":"2.8","upperLimit":"4.3","value":"3.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"title":"Investigator Assessment"}],"denoms":[{"counts":[{"groupId":"OG000","value":"82"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"DOR was defined as the number of days between the first date showing a documented response of CR or PR and the date of progression or death. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions.","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 BM-ve Population with objective response were analyzed.","reportingStatus":"POSTED","timeFrame":"From the first date of documented response of CR or PR to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)","title":"Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population","type":"SECONDARY","unitOfMeasure":"months"}