{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"0"}],"units":"Participants"}],"description":"The number of dose-limiting toxic events (DLT) for this combination of drug treatment will determine the Maximum Tolerated Dose (MTD) in subsequent phases of this study. The following events were defined as a DLT: a grade 4+ Neutropenia or platelet count decrease, a grade 4 infection, or any grade 3+ non-hematologic event as assessed using Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. Here, the number of patients reporting a DLT are reported","groups":[{"description":"Patients receive 5 mg oral everolimus once daily and 5 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Phase I: Dose Level -1"},{"description":"Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.","id":"OG001","title":"Phase I: Dose Level 0"},{"description":"Patients receive 5 mg oral everolimus once daily and 15 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.","id":"OG002","title":"Phase I: Dose Level 1"},{"description":"Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.","id":"OG003","title":"Phase II: Dose Level 0"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All Phase 1 patients that began treatment, completed 1 cycle, and were evaluated for cycle 1 toxicity were included in this analysis. Of the 9 registered to Dose Level 1, 2 were ineligible for this endpoint (PD before evaluated and dose error) and 1 cancelled. Phase II patients were not evaluated for dose-limiting toxicity.","reportingStatus":"POSTED","timeFrame":"After one 28 day cycle","title":"Number of Patients Reporting Dose-Limiting Toxicity (DLT) (Phase I)","type":"PRIMARY","unitOfMeasure":"Participants"}