{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"}],"description":"The highest dose level resulting in 0 or 1 DLT in 6 participants was to be considered the MTD of Phase 1b. Once the MTD was established, the participant cohort was expanded to a minimum of 10 participants. The MTD was confirmed by assessing DLTs during Cycle 1 and intolerable toxicities (i.e., not manageable with dose interruption and/or reduction) during Cycle 2 of therapy. Once the dose of lenvatinib/everolimus combination to be used in the succeeding Phase 2 part of the study was established, enrollment into Phase 2 was started. The RP2 dose was the same as the confirmed MTD and was used for the Phase 2 Treatment Arm A of this study.","groups":[{"description":"Oral everolimus (18 mg) and lenvatinib (5 mg) were taken once daily in the morning (consistently with or without food) with water. Any dietary habits around the time of study medication intake had to be kept as consistent as possible throughout the study.","id":"OG000","title":"Phase 1b: Dose Escalation and MTD Expansion Cohorts"}],"paramType":"NUMBER","populationDescription":"Safety analysis set included all participants who received at least one dose of study treatment.","reportingStatus":"POSTED","timeFrame":"First dose of study drug (Cycle 1 Day 1) to end of Cycle 2 (1 cycle = 28 days/4 weeks)","title":"Phase 1b: Maximum Tolerated Dose (MTD) and Recommended Phase 2 (RP2) Dose","type":"PRIMARY","unitOfMeasure":"mg/day"}