{"analyses":[{"ciNumSides":"TWO_SIDED","estimateComment":"Based on cytopenias observed at day 10 (Phase 1 trial only), and the Phase II dose was determined to be 1 mg per day for 7 consecutive days given on a 28 day cycle.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"Maximum Tolerated Dose","paramValue":"1"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"}],"units":"Participants"}],"description":"Dose-limiting toxicity was defined as any nonhematologic toxicity grade 3 or greater except for alopecia or nausea (which may be of grade 4 severity), or any grade 4 hematologic toxicity lasting more than 28 days after the last day of therapy.","groups":[{"id":"OG000","title":"Cohort 1: 10 mg/Day for 10 Days"},{"id":"OG001","title":"Cohort 2: 1 mg/Day for 10 Days"},{"id":"OG002","title":"Cohort 3: 1 mg/Day for 7 Days"},{"id":"OG003","title":"Not Evaluable"}],"paramType":"NUMBER","populationDescription":"9 out of 11 participants were evaluable for this outcome.","reportingStatus":"POSTED","timeFrame":"28 days after the first admistration of oral clofarabine","title":"Number of Participants Who Experienced a Dose-Limiting Toxicity","type":"PRIMARY","unitOfMeasure":"participants who experienced a DLT"}