{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Maximum Tolerated Dose (mg)","paramValue":"40"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"}],"units":"Participants"}],"description":"The Maximum Tolerated Dose (MTD) is defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. A total of 6 patients treated at the MTD will be sufficient to identify common toxicities at the MTD. The number of patients reporting a dose-limiting event are reported.","groups":[{"description":"Patients receive 10, 15, 20, 30 or 40 mg/day panobinostat PO 3 times/week or on days 1, 3, 5, 15, 17, and 19 and 5 or 10 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Phase I (Panobinostat + Everolimus)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The overall number of participants analyzed noted above were enrolled in and completed Phase I of the study to determine the maximum tolerated dose (MTD).","reportingStatus":"POSTED","timeFrame":"4 weeks","title":"Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)","type":"PRIMARY","unitOfMeasure":"Participants"}