{"analyses":[{"ciLowerLimit":"0.72","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.05","estimateComment":"The hazard ratio is from an unstratified Cox proportional hazards model.","groupDescription":"Median is estimated from a Kaplan-Meier distribution of EFS","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1495","paramType":"Hazard Ratio (HR)","paramValue":"0.87","statisticalComment":"2 sided unstratified","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.0","upperLimit":"8.8","value":"6.7"},{"groupId":"OG001","lowerLimit":"3.8","upperLimit":"6.0","value":"4.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"241"},{"groupId":"OG001","value":"247"}],"units":"Participants"}],"description":"Event-free survival was defined as the interval from the date of randomization to the date of treatment failure, progressive disease, relapse after complete remission (CR) or complete remission with incomplete blood count recovery (CRi), death from any cause, or lost to follow-up, whichever occurs first. Participants who were still alive without any of these events were censored at the date of their last response assessment.","dispersionType":"95% Confidence Interval","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":"MEDIAN","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 date of treatment failure, progressive disease, relapse after Complete Remission (CR) or Complete remission with incomplete blood count recovery (CRi), death from any cause. Day 1 (randomization) to 40 months","title":"Event-free Survival (EFS)","type":"SECONDARY","unitOfMeasure":"months"}