{"denoms":[{"counts":[{"groupId":"BG000","value":"239"},{"groupId":"BG001","value":"239"},{"groupId":"BG002","value":"478"}],"units":"Participants"}],"groups":[{"description":"Participants in Arm 1 will receive elacestrant\n\nElacestrant: 400 mg/day once daily oral dosing","id":"BG000","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":"BG001","title":"Standard of Care (SoC)"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"135"},{"groupId":"BG001","value":"128"},{"groupId":"BG002","value":"263"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"104"},{"groupId":"BG001","value":"111"},{"groupId":"BG002","value":"215"}],"title":">=65 years"}],"denoms":[{"counts":[{"groupId":"BG000","value":"239"},{"groupId":"BG001","value":"239"},{"groupId":"BG002","value":"478"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"233"},{"groupId":"BG001","value":"238"},{"groupId":"BG002","value":"471"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"7"}],"title":"Male"}],"denoms":[{"counts":[{"groupId":"BG000","value":"239"},{"groupId":"BG001","value":"239"},{"groupId":"BG002","value":"478"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"37"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"194"},{"groupId":"BG001","value":"191"},{"groupId":"BG002","value":"385"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"56"}],"title":"Unknown or Not Reported"}],"denoms":[{"counts":[{"groupId":"BG000","value":"239"},{"groupId":"BG001","value":"239"},{"groupId":"BG002","value":"478"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"7.860","value":"162.27"},{"groupId":"BG001","spread":"7.149","value":"160.97"},{"groupId":"BG002","spread":"7.532","value":"161.62"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"236"},{"groupId":"BG001","value":"237"},{"groupId":"BG002","value":"473"}],"units":"Participants"}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","populationDescription":"Data was not collected for five participants","title":"Height","unitOfMeasure":"cm"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"16.093","value":"72.70"},{"groupId":"BG001","spread":"16.390","value":"72.39"},{"groupId":"BG002","spread":"16.226","value":"72.55"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"239"},{"groupId":"BG001","value":"239"},{"groupId":"BG002","value":"478"}],"units":"Participants"}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Weight","unitOfMeasure":"kg"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"5.494","value":"27.58"},{"groupId":"BG001","spread":"5.853","value":"27.92"},{"groupId":"BG002","spread":"5.673","value":"27.75"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"236"},{"groupId":"BG001","value":"237"},{"groupId":"BG002","value":"473"}],"units":"Participants"}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","populationDescription":"Data was not collected for five participants","title":"Body Mass Index","unitOfMeasure":"kg/m^2"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"143"},{"groupId":"BG001","value":"135"},{"groupId":"BG002","value":"278"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"239"},{"groupId":"BG001","value":"239"},{"groupId":"BG002","value":"478"}],"units":"Participants"}],"title":"0: Fully active, able to carry on all pre-disease performance without restriction"},{"categories":[{"measurements":[{"groupId":"BG000","value":"96"},{"groupId":"BG001","value":"103"},{"groupId":"BG002","value":"199"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"239"},{"groupId":"BG001","value":"239"},{"groupId":"BG002","value":"478"}],"units":"Participants"}],"title":"1: Restricted in physically strenuous activity but ambulatory & can carry out light, sedentary work"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"239"},{"groupId":"BG001","value":"239"},{"groupId":"BG002","value":"478"}],"units":"Participants"}],"title":"2: Ambulatory and capable of all selfcare but unable to carry out any work activities"}],"description":"Participants were graded on a scale from 0 to 5, where 5 was the worst:\n\n0\\. Normal activity. Fully active, able to carry on all pre-disease performance without restriction\n\n1. Symptoms, but ambulatory. Restricted in strenuous activity, ambulatory and able to carry out light work\n2. In bed \\<50% of time. Ambulatory, capable of all self-care, unable to carry out any work activities\n3. In bed \\>50% of time. Capable of limited self-care\n4. 100% bedridden. Completely disabled. Cannot carry out any self-care. Confined to bed or chair\n5. Dead","paramType":"COUNT_OF_PARTICIPANTS","title":"Eastern Cooperative Oncology Group Performance Status","unitOfMeasure":"Participants"}]}