{"analyses":[{"ciNumSides":"TWO_SIDED","estimateComment":"Dose Level 1 was chosen as the MTD due to PI concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2. For the best interest of the patients, dose level 1 was chosen as the MTD and the dose level for Phase II.","groupDescription":"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 (at least 2 of a maximum of 6 new patients).","groupIds":["OG000","OG001","OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Maximum Tolerated Dose (MTD) Level","paramValue":"1"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"5"}],"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 (at least 2 of a maximum of 6 new patients). Dose-limiting toxicity (DLT) is defined as an adverse event attributed (definitely, probably, or possibly) in first cycle to the study treatment and meeting the following criteria:\n\n* Grade 4 infection\n* Grade 4 ANC or PLT\n* Grade 3 or higher non-hematologic adverse event.\n\nNCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0 will be used to assess adverse events. For this endpoint, the number of patients reporting a DLT event are tabulated.","groups":[{"description":"Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day","id":"OG000","title":"Phase I, Dose Level 0"},{"description":"Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day","id":"OG001","title":"Phase I, Dose Level 1"},{"description":"Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day","id":"OG002","title":"Phase I, Dose Level 2"},{"description":"Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day","id":"OG003","title":"Phase I, Dose Level 3"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"First cycle (28 days) of study treatment","title":"Number of Participants Reporting a Dose Limiting Toxicity (DLT)","type":"PRIMARY","unitOfMeasure":"participants"}