{"denoms":[{"counts":[{"groupId":"BG000","value":"347"},{"groupId":"BG001","value":"174"},{"groupId":"BG002","value":"521"}],"units":"Participants"}],"groups":[{"description":"Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.","id":"BG000","title":"Palbociclib + Fulvestrant"},{"description":"Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.","id":"BG001","title":"Placebo + Fulvestrant"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"11.7","value":"56.9"},{"groupId":"BG001","spread":"10.4","value":"56.8"},{"groupId":"BG002","spread":"11.3","value":"56.9"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"347"},{"groupId":"BG001","value":"174"},{"groupId":"BG002","value":"521"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"28"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"329"},{"groupId":"BG001","value":"161"},{"groupId":"BG002","value":"490"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"275"},{"groupId":"BG001","value":"138"},{"groupId":"BG002","value":"413"}],"title":"Postmenopausal"},{"measurements":[{"groupId":"BG000","value":"72"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"108"}],"title":"Pre/Perimenopausal"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Menopausal Status","unitOfMeasure":"Participants"}],"populationDescription":"The intent-to-treat (ITT) population or full analysis set included all participants who were randomized, with study intervention assignment designated according to initial randomization, regardless of whether participants received study intervention or received a different drug from that to which they were randomized."}