{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.8","upperLimit":"36.6","value":"22.4"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"13.7","value":"0.0"},{"groupId":"OG002","lowerLimit":"6.8","upperLimit":"40.7","value":"20.0"},{"groupId":"OG003","lowerLimit":"8.6","upperLimit":"42.3","value":"22.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"25"},{"groupId":"OG003","value":"27"}],"units":"Participants"}],"description":"Complete response rate is defined as the percentage of participants achieving a complete response (CR) based on the 2003 revised IWG criteria for AML or the 2006 modified IWG criteria for MDS as assessed by the investigator. CR for AML: - Absolute neutrophil count (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 CR for MDS: - Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines - Peripheral blood: -- Hemoglobin ≥ 11 g/dL -- Platelets ≥ 100 × 10⁹/L -- Neutrophils ≥ 1.0 × 10⁹/L -- Blasts = 0%","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants ≥ 60 years old with relapsed, refractory AML or participants of any age if relapsed post-bone marrow transplant (BMT) received 100 mg enasidenib QD 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 Expansion Arm 1: Enasidenib 100 mg QD"},{"description":"Participants \\< 60 years old with R/R AML, excluding participants who relapsed post-BMT, received 100 mg enasidenib QD 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 Expansion Arm 2: Enasidenib 100 mg QD"},{"description":"Untreated AML participants ≥ 60 years old who declined standard of care received 100 mg enasidenib QD 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 Expansion Arm 3: Enasidenib 100 mg QD"},{"description":"Participants with advanced hematologic malignancies not eligible for Arms 1 to 3 received 100 mg enasidenib QD 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 Expansion Arm 4: Enasidenib 100 mg QD"}],"paramType":"NUMBER","populationDescription":"All participants in Phase 1 Dose Expansion who received at least one dose of study treatment.","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 Phase 1 Dose Expansion was 5.2 months (range 0.5 to 32.8 months).","title":"Phase 1 Dose Expansion: Complete Response Rate","type":"SECONDARY","unitOfMeasure":"percentage of participants"}