{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"52.7","upperLimit":"399","value":"201"},{"groupId":"OG001","lowerLimit":"29.8","upperLimit":"146","value":"80.1"},{"groupId":"OG002","lowerLimit":"119","upperLimit":"176","value":"147.5"},{"groupId":"OG003","lowerLimit":"42.5","upperLimit":"75.5","value":"59"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"}],"units":"Participants"}],"description":"Everolimus plasma concentration-time data obtained from patients who received Phase I defined treatment will be modeled using compartmental approaches to estimate the AUC (hr\\*nM) for each dose level on day 17 of course 1 and day 1 of course 2. Patients who were enrolled in the Surgical stratum but subsequently received Phase I defined treatment with PK data available will also be included in the analysis population. 5 patients from surgical stratum received dose level 1 treatment.","dispersionType":"Full Range","groups":[{"description":"Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 17 of Course 1.","id":"OG000","title":"Dose Level 1, Day 17 of Course 1"},{"description":"Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 120 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 1 of Course 2.","id":"OG001","title":"Dose Level 1, Day 1 of Course 2"},{"description":"Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 17 of Course 1.","id":"OG002","title":"Dose Level 2, Day 17 of Course 1"},{"description":"Patients receive ribociclib PO QD on days 1-21 of course 1 and subsequent courses and days 2-21 of course 2 at 170 mg/m2/day, and everolimus PO QD on days 3-28 of course 1 and days 1-28 of subsequent courses at 1.2 mg/m2/day. Samples are collected on Day 1 of Course 2.","id":"OG003","title":"Dose Level 2, Day 1 of Course 2"}],"paramType":"MEDIAN","populationDescription":"Patients with blood samples collected for pharmacokinetic studies on day 17 of course 1 and day 1 of course 2 were included. Surgical patients who received Phase I treatment with samples collected were also included in Dose Level 1. There are total 17 patients received dose level 1 treatment and 3 patients received dose level 2 treatment. Analysis population only includes treated patients with corresponding PK data available.","reportingStatus":"POSTED","timeFrame":"Pre-dose, 0.5 (course 2 only), 1, 1.5 (course 2 only), 2, 4, 6 (course 2 only), 8, 24 hours after dose on day 17 of course 1, and day 1 of course 2.","title":"Everolimus AUC (Area Under the Plasma Concentration Versus Time Curve) as Obtained From the Phase I Study","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"hr*nM"}