{"denoms":[{"counts":[{"groupId":"BG000","value":"241"},{"groupId":"BG001","value":"247"},{"groupId":"BG002","value":"488"}],"units":"Participants"}],"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":"BG000","title":"Azacitidine (AZA)"},{"description":"#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. 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 SC twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only includes transfusion of blood products, antibiotics, antifungals and nutritional help.","id":"BG001","title":"Conventional Care Regimens (CCR)"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"5.60","value":"75.4"},{"groupId":"BG001","spread":"5.57","value":"75.1"},{"groupId":"BG002","spread":"5.58","value":"75.2"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"103"},{"groupId":"BG001","value":"120"},{"groupId":"BG002","value":"223"}]}],"title":"<75 years"},{"categories":[{"measurements":[{"groupId":"BG000","value":"138"},{"groupId":"BG001","value":"127"},{"groupId":"BG002","value":"265"}]}],"title":"≥75 years"}],"paramType":"NUMBER","title":"Age, Customized","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"102"},{"groupId":"BG001","value":"98"},{"groupId":"BG002","value":"200"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"139"},{"groupId":"BG001","value":"149"},{"groupId":"BG002","value":"288"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54"},{"groupId":"BG001","value":"57"},{"groupId":"BG002","value":"111"}]}],"title":"0 = Fully Active"},{"categories":[{"measurements":[{"groupId":"BG000","value":"132"},{"groupId":"BG001","value":"132"},{"groupId":"BG002","value":"264"}]}],"title":"1 = Restrictive but Ambulatory"},{"categories":[{"measurements":[{"groupId":"BG000","value":"55"},{"groupId":"BG001","value":"58"},{"groupId":"BG002","value":"113"}]}],"title":"2 = Ambulatory but unable to work"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}],"title":"3 = Limited Self Care"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}],"title":"4 = Completely disabled"}],"description":"ECOG performance status is used by doctors and researchers to assess how a participants disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity), 1 = Restricted activity but ambulatory, 2 = Ambulatory but unable to carry out work activities, 3 = Limited Self Care; 4 = Completely Disabled, No self care (Least Favorable Activity)","paramType":"NUMBER","title":"Eastern Cooperative Oncology Group (ECOG) Performance Status","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"75"},{"groupId":"BG001","value":"83"},{"groupId":"BG002","value":"158"}]}],"title":"AML with myelodysplasia-related changes"},{"categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"158"}]}],"title":"Therapy-related myeloid neoplasms"},{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"14"}]}],"title":"AML with recurrent genetic abnormalities"},{"categories":[{"measurements":[{"groupId":"BG000","value":"153"},{"groupId":"BG001","value":"143"},{"groupId":"BG002","value":"296"}]}],"title":"AML not otherwise specified"}],"description":"WHO categories include:\n\n1. Those with AML with recurrent genetic abnormalities. Includes subtypes with multiple chromosome translocations and mutations.\n2. Those with AML with myelodysplasia-related changes. Includes those with prior myelodysplastic syndrome (MDS) or myeloproliferative disease and has transformed to AML.\n3. Those with therapy related myeloid neoplasms and have had prior chemotherapy and/or radiation and subsequently develop AML or MDS\n4. Those with AML not otherwise specified and include subtypes that do not fall into the above categories.","paramType":"NUMBER","title":"World Health Organization Acute Myeloid Leukemia (AML) Classification","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"24.71","value":"66.6"},{"groupId":"BG001","spread":"22.28","value":"70.2"},{"groupId":"BG002","spread":"23.56","value":"68.5"}]}]}],"description":"Baseline clinical characteristics, including percentage of bone marrow blasts were assessed centrally and locally. Central values are included here. Baseline blasts were the last non-missing value on or prior to the date of randomization. The bone marrow blasts cells are not typically found in the circulating blood of healthy individuals. Abnormal immature white blood cells (blasts) fill the bone marrow and spill into the bloodstream.","dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Bone Marrow-Blasts Counts","unitOfMeasure":"Percentage of Bone Marrow Blasts"}],"populationDescription":"The intent-to-treat (ITT) population is defined as all participants who were randomized, independent of whether they received study treatment or not."}