{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"7"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"6"},{"groupId":"OG009","value":"6"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"5"},{"groupId":"OG012","value":"5"}],"units":"Participants"}],"description":"Toxicity severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. A DLT was defined as: • Non-hematologic toxicities: CTCAE ≥ Grade 3 with the exception of ≥ Grade 3 blood bilirubin increases in participants with a uridine diphosphate- glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) mutation. In participants with a UGT1A1 mutation, blood bilirubin increases of \\> 5× upper limit of normal (ULN) were considered a DLT. • Hematologic toxicities: Prolonged myelosuppression, defined as persistence of ≥ Grade 3 neutropenia or thrombocytopenia (by NCI CTCAE v4.03), leukemia-specific criteria, i.e., marrow cellularity \\<5% on Day 28 or later from the start of study drug without evidence of leukemia) at least 42 days after the initiation of Cycle 1 therapy. Leukemia-specific grading was used for cytopenias (based on percentage decrease from Baseline: 50 to 75% = Grade 3, \\>75% = Grade 4)","groups":[{"description":"Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG000","title":"Phase 1 Dose Escalation: Enasidenib 30 mg BID"},{"description":"Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG001","title":"Phase 1 Dose Escalation: Enasidenib 50 mg BID"},{"description":"Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG002","title":"Phase 1 Dose Escalation: Enasidenib 75 mg BID"},{"description":"Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG003","title":"Phase 1 Dose Escalation: Enasidenib 100 mg BID"},{"description":"Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG004","title":"Phase 1 Dose Escalation: Enasidenib 150 mg BID"},{"description":"Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG005","title":"Phase 1 Dose Escalation: Enasidenib 50 mg QD"},{"description":"Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG006","title":"Phase 1 Dose Escalation: Enasidenib 75 mg QD"},{"description":"Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG007","title":"Phase 1 Dose Escalation: Enasidenib 100 mg QD"},{"description":"Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG008","title":"Phase 1 Dose Escalation: Enasidenib 150 mg QD"},{"description":"Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG009","title":"Phase 1 Dose Escalation: Enasidenib 200 mg QD"},{"description":"Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG010","title":"Phase 1 Dose Escalation: Enasidenib 300 mg QD"},{"description":"Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG011","title":"Phase 1 Dose Escalation: Enasidenib 450 mg QD"},{"description":"Participants received enasidenib 650 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.","id":"OG012","title":"Phase 1 Dose Escalation: Enasidenib 650 mg QD"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All participants who took at least one dose of study drug in the dose escalation phase and either had a DLT during Cycle 1, regardless of the amount of study drug exposure, or had no DLT and completed at least 75% of their planned Cycle 1 doses, and were considered to have had enough safety data to conclude that a DLT did not occur during Cycle 1.","reportingStatus":"POSTED","timeFrame":"From time of first dose up to the end of Cycle 1; 28 days","title":"Phase 1 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLT)","type":"PRIMARY","unitOfMeasure":"Participants"}