{"analyses":[{"ciLowerLimit":"0.75","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.66","estimateComment":"The hazard ratio is from an unstratified Cox proportional hazards model.","groupDescription":"Median is estimated from a Kaplan-Meier distribution of RFS","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.5832","paramType":"Hazard Ratio (HR)","paramValue":"1.11","statisticalComment":"2 sided unstratified","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.7","upperLimit":"12.4","value":"9.3"},{"groupId":"OG001","lowerLimit":"7.3","upperLimit":"12.3","value":"10.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"62"}],"units":"Participants"}],"description":"Relapse-free survival was defined as the interval from the date of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up, whichever occurred first. Participants who were still alive and in continuous CR or CRi 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 Regimen"}],"paramType":"MEDIAN","populationDescription":"Participants who achieved a CR or CRi","reportingStatus":"POSTED","timeFrame":"Day 1 of first documented CR or CRi to the date of relapse, death from any cause, or lost to follow-up. Day 1 (randomization) to 40 months","title":"Relapse-Free Survival (RFS) for Participants Who Achieved a Complete Remission (CR) or Complete Remission With Incomplete Blood Count Recovery (CRi)","type":"SECONDARY","unitOfMeasure":"months"}