{"analyses":[{"ciLowerLimit":"0.536","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.025","estimateComment":"Applied a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: ESR1-mutational status (ESR1-mut vs ESR1-wt), prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no).","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0697","paramType":"Hazard Ratio (HR)","paramValue":"0.742","statisticalComment":"The p-value was generated by using a two-sided stratified log-rank test.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA=not calculable (insufficient number of participants with events)","groupId":"OG000","lowerLimit":"19.29","upperLimit":"NA","value":"NA"},{"comment":"NA=not calculable (insufficient number of participants with events)","groupId":"OG001","lowerLimit":"15.80","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"239"}],"units":"Participants"}],"description":"Overall survival in all (ESR1-mut and ESR1-wt) participants.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants in Arm 1 will receive elacestrant\n\nElacestrant: 400 mg/day once daily oral dosing","id":"OG000","title":"Elacestrant"},{"description":"Participants in Arm 2 will receive Investigator's choice of one of the standard-of-care drugs (fulvestrant, anastrozole, letrozole, or exemestane)\n\nStandard of Care:\n\n* Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle\n* Anastrozole 1 mg/day on a continuous dosing schedule\n* Letrozole: 2.5 mg/day on a continuous dosing schedule\n* Exemestane: 25 mg/day on a continuous dosing schedule","id":"OG001","title":"Standard of Care (SoC)"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)","title":"Overall Survival in All Participants","type":"SECONDARY","unitOfMeasure":"months"}