{"analyses":[{"ciLowerLimit":"0.387","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.768","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":"0.0005","paramType":"Hazard Ratio (HR)","paramValue":"0.546","statisticalComment":"The p-value was generated by using a two-sided stratified log-rank test.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.17","upperLimit":"7.26","value":"3.78"},{"groupId":"OG001","lowerLimit":"1.87","upperLimit":"2.14","value":"1.87"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"115"},{"groupId":"OG001","value":"113"}],"units":"Participants"}],"description":"Progression-free survival based on blinded IRC assessment in ESR1-mut participants defined as the length of time from randomization until the date of objective disease progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by the blinded IRC or death from any cause. Progression is defined per RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.","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 ESR1-mut Participants","type":"PRIMARY","unitOfMeasure":"months"}