{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"41","value":"11.75"},{"groupId":"OG001","spread":"52","value":"9.31"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"19"}],"units":"Participants"}],"title":"Cycle 2/Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"42","value":"9.90"},{"groupId":"OG001","spread":"72","value":"7.60"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"14"}],"units":"Participants"}],"title":"Cycle 3/Day 1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"33"}],"units":"Participants"}],"description":"Ctrough was defined as steady-state predose concentration. Observed directly from data. For fulvestrant, 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 Fulvestrant","type":"SECONDARY","unitOfMeasure":"ng/mL"}