{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"32.2","upperLimit":"45.7","value":"38.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"214"}],"units":"Participants"}],"description":"For participants with R/R AML ORR is defined as the percentage of participants achieving an overall response of CR, CRi, CRp, PR, or MLFS based on the 2003 revised IWG criteria for AML. 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","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants in Phase 1 or 2 with relapsed or refractory (R/R) AML who 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":"Enasidenib 100 mg QD"}],"paramType":"NUMBER","populationDescription":"All participants in Phase 1 and 2 with R/R AML 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 for Phase 1 and 2 R/R AML participants was 5.4 months (range 0.4 to 34.2 months).","title":"Combined Phase 1/2: Investigator Assessed Overall Response Rate in Participants With R/R AML","type":"SECONDARY","unitOfMeasure":"percentage of participants"}