{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"88.1","value":"378"},{"groupId":"OG001","spread":"263","value":"463"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"description":"Between 9 and 12 participants in each of the 3 treatment arms participated in an optional substudy where instead of the sparse sampling, 9 samples were to be taken over 1 single 24-hour period (i.e., intensive sampling) for full PK profiling. Blood samples were analyzed for study drug using standardized methods. PK parameters for everolimus were derived from everolimus concentration data using non-compartmental methods. Data were compared via descriptive statistics between single agent and combination therapy.","dispersionType":"Standard Deviation","groups":[{"description":"Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.","id":"OG000","title":"Phase 2: 18 mg Lenvatinib + 5 mg Everolimus"},{"description":"Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.","id":"OG001","title":"Phase 2: 10 mg Everolimus"}],"paramType":"MEAN","populationDescription":"PK sub analysis set. n=8 for AUC(0-24)","reportingStatus":"POSTED","timeFrame":"Phase 2: Cycle 1 Day 15 immediately predose, and 30 minutes, 1, 2, 3, 4, 8, 12 (optional), and 24 hours postdose (predose on Day 16)","title":"Area Under the Blood Concentration-Time Curve From 0 to 24 Hours for Everolimus When Administered Alone or in Combination With Lenvatinib","type":"SECONDARY","unitOfMeasure":"ng·hr/mL"}