{"analyses":[{"ciLowerLimit":"0.361","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.958","groupDescription":"The analysis was performed using a stratified Cox Proportional Hazards model with ties=Efron and the stratification factors: prior treatment with fulvestrant (yes vs no) and presence of visceral metastases (yes vs no); the CI calculated using a profile likelihood approach.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0325","pValueComment":"The p-value was generated by using a two-sided stratified log-rank test.","paramType":"Hazard Ratio (HR)","paramValue":"0.592","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA=not calculable (insufficient number of participants with events)","groupId":"OG000","lowerLimit":"18.60","upperLimit":"NA","value":"NA"},{"comment":"NA=not calculable (insufficient number of participants with events)","groupId":"OG001","lowerLimit":"14.00","upperLimit":"NA","value":"16.95"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"113"}],"units":"Participants"}],"description":"Overall survival in ESR1-mut participants, where overall survival is defined as the length of time from randomization until the date of death from any cause.","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 ESR1-mut Participants","type":"SECONDARY","unitOfMeasure":"months"}