{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"234"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"153"},{"groupId":"OG003","value":"42"}]}],"title":"At least one Treatment Emergent AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"188"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"124"},{"groupId":"OG003","value":"39"}]}],"title":"At least one TEAE related to study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"207"},{"groupId":"OG001","value":"26"},{"groupId":"OG002","value":"141"},{"groupId":"OG003","value":"37"}]}],"title":"Grade 3-4 adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"90"},{"groupId":"OG003","value":"29"}]}],"title":"Grade 3-4 adverse event related to any study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"38"},{"groupId":"OG003","value":"9"}]}],"title":"At least one Grade 5 (leading to death) TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"4"}]}],"title":"Grade 5 adverse event related to any study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"188"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"118"},{"groupId":"OG003","value":"27"}]}],"title":"Serious TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"56"},{"groupId":"OG003","value":"14"}]}],"title":"Serious TEAE related to any study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"110"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"68"},{"groupId":"OG003","value":"11"}]}],"title":"TEAE leading to discontinuation of study drug"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"5"}]}],"title":"Study drug-related TEAE leading to discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"}]}],"title":"TEAE leading to study drug dose reduction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"116"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"61"},{"groupId":"OG003","value":"4"}]}],"title":"TEAE leading to study drug dose interruption"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"0"}]}],"title":"TEAE causing study drug dose reduction/disruption"}],"denoms":[{"counts":[{"groupId":"OG000","value":"236"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"153"},{"groupId":"OG003","value":"42"}],"units":"Participants"}],"description":"AEs = any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, regardless of cause. Serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0); AEs were evaluated for severity according to the following scale: Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening; Grade 5 = Death","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":"Best supportive care included red blood cell (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic and/or antifungal therapy, and nutritional support.","id":"OG001","title":"Conventional Care Regimen #3 Best Supportive Care Only"},{"description":"Low-dose cytarabine 20 mg SC injection twice a day (BID) for 10 days, every 28 days (optimally for at least 4 cycles) until the end of the study, unless participants were discontinued from the treatment. Best supportive care as needed, including antibiotics and transfusions, per physicians discretion.","id":"OG002","title":"Conventional Care Regimen #2 Low-dose Cytarabine"},{"description":"Induction Therapy included Cytarabine 100-200 mg/m\\^2 as a continuous intravenous infusion (IV) for 7 days plus daunorubicin 45 to 60 mg/m\\^² daily IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m\\^² IV daily for 3 days as an alternative to daunorubicin (Cycle 1). Consolidation Therapy (Cycle 2 and 3) Cytarabine 100-200 mg/m\\^2 as a continuous IV infusion for a total of 3 to 7 days plus daunorubicin 45 to 60 mg/m\\^² daily or Idarubicin 9-12 mg/m\\^² IV daily on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from commencement of induction therapy, upon recovery of absolute neutrophil count (ANC) to at least 1.0 x 10\\^9/L and platelets to at least 75 x 10\\^9/L. The second consolidation cycle, if given, started between Day 28 and Day 70 from commencement of the first consolidation therapy. Participants could receive BSC as needed, including antibiotics and transfusions, physicians discretion.","id":"OG003","title":"Conventional Care Regimen #1 Intensive Chemotherapy"}],"paramType":"NUMBER","populationDescription":"Safety population = all randomized participants who received at least 1 dose of study drug and had 1 post-dose safety assessment. Because the BSC only regimen consisted of blood products or antibiotics given as needed, those assigned to BSC only were included in the safety population if they had at least 1 post-randomization safety assessment.","reportingStatus":"POSTED","timeFrame":"Day 1 (randomization) up to last visit completed; final data cut off of 28 Feb 2017","title":"Number of Participants With Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"participants"}