{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"44","value":"70.70"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"165"}],"units":"Participants"}],"title":"Cycle 1/Day 15"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"44","value":"75.29"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"}],"units":"Participants"}],"title":"Cycle 2/Day 15"}],"denoms":[{"counts":[{"groupId":"OG000","value":"325"}],"units":"Participants"}],"description":"Ctrough was defined as steady-state predose concentration. Observed directly from data. For palbociclib, a steady-state trough was to be defined as a predose plasma concentration following at least 8 consecutive days of 125 mg daily dose without dosing interruption and the time window for the PK collection was to be between 22 and 26 hours after the dose (the day prior to PK collection) and no more than 1 hour post-dose on the day of PK collection.","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"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"The participants who were treated with Palbociclib + fulvestrant (with or without goserelin) or placebo + fulvestrant (with or without goserelin) and have at least one measured plasma drug concentration. The geometric mean and coefficient of variation was not estimable for Cycle 1/Day 15 and Cycle 2/Day 15 for the reporting arm placebo plus fulvestrant.","reportingStatus":"POSTED","timeFrame":"Cycle 1/Day 15 and Cycle 2/Day 15","title":"Observed Plasma Trough Concentration (Ctrough) for Palbociclib","type":"SECONDARY","unitOfMeasure":"nanograms per milliliter (ng/mL)"}