{"analyses":[{"ciLowerLimit":"0.552","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.880","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":"0.0018","paramType":"Hazard Ratio (HR)","paramValue":"0.697","statisticalComment":"The p-value was generated by using a two-sided stratified log-rank test.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.94","upperLimit":"3.78","value":"2.79"},{"groupId":"OG001","lowerLimit":"1.87","upperLimit":"2.10","value":"1.91"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"239"},{"groupId":"OG001","value":"239"}],"units":"Participants"}],"description":"Progression-free survival based on blinded imaging review committee (IRC) assessment 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 Disease Progression or Death Due to Any Cause (up to 12 Months)","title":"Progression-free Survival in All Participants","type":"PRIMARY","unitOfMeasure":"months"}