{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.5384","statisticalComment":"P-value is from Fishers exact test","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27.8"},{"groupId":"OG001","value":"25.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"241"},{"groupId":"OG001","value":"247"}],"units":"Participants"}],"description":"A complete remission (CR) is defined as a leukemia-free state defined as less than 5% blasts in a BM aspirate with marrow spicules and with at least 200 nucleated cells (there should be no blasts with Auer rods), an absolute neutrophil count (ANC) of ≥ 1 x 10\\^9/L, a platelet count ≥ 100 x 10\\^9/L, and transfusion independence (no transfusions for 1 week prior to each assessment). No duration of these findings is required for confirmation of this response. A CR with incomplete blood count recovery (CRi) is defined as \\<5% BM blasts with the ANC count \\< 1 x 10\\^9/L and/or the platelet count may be \\< 100 x 10\\^9/L. Where the date of the hematology assessment used is the earliest on or following the date of the BM sample up to 8 days after the BM date.","groups":[{"description":"Azacitidine 75 mg/m2/day by subcutaneous injection \\[SC\\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.","id":"OG000","title":"Azacitidine (AZA)"},{"description":"CCRs included: #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m\\^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m\\^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m\\^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m\\^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m\\^² QD or Idarubicin 9-12 mg/m\\^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10\\^9/L and platelets above 75 x 10\\^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed # 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help","id":"OG001","title":"Conventional Care Regimens (CCR)"}],"paramType":"NUMBER","populationDescription":"The intent-to-treat (ITT) population was defined as all participants who were randomized, independent of whether they received study treatment or not. Includes participants who died and participants who were censored","reportingStatus":"POSTED","timeFrame":"Day 1 (randomization) to 40 months","title":"Percentage of Participants Who Achieved a Morphologic CR + CRi as Determined by the Independent Review Committee (IRC) Based on International Working Group (IWG) Response Criteria for Acute Myeloid Leukemia (AML)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}