{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"OTHER","paramType":"Maximum Tolerated Dose (mg)","paramValue":"30"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"}],"units":"Participants"}],"description":"The Maximum Tolerated Dose (MTD) of sapanisertib (MLN0128) 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 4.0. Dose-limiting toxicities include non-hematologic events graded 3 or higher and deemed at least possibly related to treatment. The number of patients reporting a dose-limiting event is reported.","groups":[{"description":"Protocol therapy will consist of 20 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.","id":"OG000","title":"Phase I - Dose Level 0"},{"description":"Protocol therapy will consist of 25 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.","id":"OG001","title":"Phase I - Dose Level 1"},{"description":"Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly on days 1, 8, 15, and 22 over a 28-day cycle.","id":"OG002","title":"Phase I - Dose Level 2"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Phase I","reportingStatus":"POSTED","timeFrame":"28 days","title":"Number of Phase I Participants With Dose-Limiting Toxicity Events (Phase I)","type":"PRIMARY","unitOfMeasure":"Participants"}