{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.5","upperLimit":"70.1","value":"33.3"},{"groupId":"OG001","lowerLimit":"9.9","upperLimit":"81.6","value":"42.9"},{"groupId":"OG002","lowerLimit":"0.4","upperLimit":"57.9","value":"14.3"},{"groupId":"OG003","lowerLimit":"26.4","upperLimit":"64.3","value":"44.8"},{"groupId":"OG004","lowerLimit":"19.2","upperLimit":"74.9","value":"46.2"},{"groupId":"OG005","lowerLimit":"28.2","upperLimit":"71.8","value":"50.0"},{"groupId":"OG006","lowerLimit":"12.8","upperLimit":"64.9","value":"35.7"},{"groupId":"OG007","lowerLimit":"14.7","upperLimit":"94.7","value":"60.0"},{"groupId":"OG008","lowerLimit":"29.0","upperLimit":"96.3","value":"71.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"29"},{"groupId":"OG004","value":"13"},{"groupId":"OG005","value":"22"},{"groupId":"OG006","value":"14"},{"groupId":"OG007","value":"5"},{"groupId":"OG008","value":"7"}],"units":"Participants"}],"description":"ORR is defined as the percentage of participants achieving an overall response of CR, CRi, CRp, PR, marrow CR (mCR) (for MDS) and MLFS (for AML) based on the 2003 revised IWG criteria for AML and 2006 modified IWG criteria for MDS. CR: • ANC \\> 1.0 x10⁹/L • Platelet count \\> 100 x10⁹/L • Bone marrow (BM) blasts \\< 5% • Absence of blasts with Auer rods • Independence of red cell transfusions CRi: • All CR criteria except for residual neutropenia (ANC \\< 1.0 x 10⁹/L CRp: • All CR criteria except for residual thrombocytopenia (platelet counts \\< 100 x 10⁹/L) PR: • Meets hematologic criteria of CR • Decrease of BM blasts to 5-25% and decrease of pretreatment BM blast ≥ 50%. MLFS: • Bone marrow blasts \\< 5% • Absence of blasts with Auer rods • Absence of extramedullary disease • No hematologic recovery required mCR: • Bone marrow myeloblasts ≤ 5% and decreased by ≥ 50%","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received enasidenib 50 mg 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 50 mg"},{"description":"Participants who received a total daily dose of enasidenib 60 mg 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 60 mg"},{"description":"Participants who received a total daily dose of enasidenib 75 mg 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"},{"description":"Participants who received a total daily dose of enasidenib 100 mg 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"},{"description":"Participants who received a total daily dose of enasidenib 150 mg 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"},{"description":"Participants who received a total daily dose of enasidenib 200 mg 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 200 mg"},{"description":"Participants who received a total daily dose of enasidenib 300 mg 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 300 mg"},{"description":"Participants who received a total daily dose of enasidenib 450 mg 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 450 mg"},{"description":"Participants who received a total daily dose of enasidenib 650 mg 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 650 mg"}],"paramType":"NUMBER","populationDescription":"All participants who received at least one dose of study treatment in Phase 1 Dose Escalation. Participants were grouped according to assigned total daily dose.","reportingStatus":"POSTED","timeFrame":"Response assessments were performed every 28 days through Month 12 and every 56 days thereafter until the end of treatment; median duration of treatment exposure in the dose escalation phase was 5.0 months (range 0.4 to 34.2 months).","title":"Phase 1 Dose Escalation: Investigator Assessed Overall Response Rate (ORR) by Total Daily Dose","type":"SECONDARY","unitOfMeasure":"percentage of participants"}