{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"27.9","upperLimit":"47.1","value":"37.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"105"}],"units":"Participants"}],"description":"ORR is defined as the percentage of participants achieving an overall response of complete response (CR), CR with incomplete neutrophil recovery (CRi), CR with incomplete platelet recovery (CRp), partial response (PR), or morphologic leukemia-free state (MLFS) based on the 2003 revised International Working Group (IWG) criteria for AML, assessed by the Investigator. CR: • 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 CRi: • All CR criteria except for residual neutropenia (ANC \\< 1.0 x 10⁹/L CRp: • All CR criteria except for residual thrombocytopenia (platelets \\< 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","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received enasidenib 100 mg 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 2: Enasidenib 100 mg QD"}],"paramType":"NUMBER","populationDescription":"All participants In Phase 2 with R/R AML who received at least 1 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 2 was 5.3 months (range 0.4 to 22.5 months).","title":"Phase 2 Dose Expansion: Investigator Assessed Overall Response Rate (ORR)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}