{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.0","upperLimit":"18.0","value":"11.7"},{"groupId":"OG001","lowerLimit":"7.3","upperLimit":"17.3","value":"8.9"},{"groupId":"OG002","lowerLimit":"8.4","upperLimit":"13.9","value":"8.5"},{"groupId":"OG003","lowerLimit":"5.5","upperLimit":"9.5","value":"7.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"}],"units":"Participants"}],"description":"Ribociclib plasma concentration-time data obtained from patients received Phase I defined treatment will be modeled using compartmental approaches to estimate the half-life (hrs) for each dose level on days 1 and 17 of course 1. 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 1 of Course 1.","id":"OG000","title":"Dose Level 1, Day 1 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 17 of Course 1.","id":"OG001","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 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 1.","id":"OG002","title":"Dose Level 2, Day 1 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 17 of Course 1","id":"OG003","title":"Dose Level 2, Day 17 of Course 1"}],"paramType":"MEDIAN","populationDescription":"Patients with blood samples collected for pharmacokinetic studies on days 1 and 17 of course 1 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. The analysis population only includes patients with corresponding PK data available at that timepoint.","reportingStatus":"POSTED","timeFrame":"Pre-dose, 1, 2, 4, 8, 24, 32 (day 1 course 1 only), & 48 (day 1 course 1 only) hours after dose on days 1 and 17 of course 1.","title":"Ribociclib Half-Life as Obtained From the Phase 1 Study","type":"OTHER_PRE_SPECIFIED","unitOfMeasure":"hours"}