{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"153","value":"295.1"},{"groupId":"OG001","spread":"74","value":"302.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"title":"Cycle 2/Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"64","value":"344.8"},{"groupId":"OG001","spread":"40","value":"288.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"3"}],"units":"Participants"}],"title":"Cycle 3/Day 1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"description":"Ctrough was defined as steady-state predose concentration. Observed directly from data. For goserelin, a steady-state trough was to be defined when a patient had received all prior planned doses and the sample was collected predose.","dispersionType":"Geometric Coefficient of Variation","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":"OG000","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":"OG001","title":"Placebo + Fulvestrant"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"The 40 participants who participated in the early safety review, who are treated with palbociclib + fulvestrant ± goserelin or placebo + fulvestrant ± goserelin and have at least one measured plasma drug concentration.","reportingStatus":"POSTED","timeFrame":"Cycles 2/ Day 1 and Cycle 3/ Day 1","title":"Ctrough for Goserelin","type":"SECONDARY","unitOfMeasure":"picograms per milliliter (pg/mL)"}