{"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":"FG000","title":"Azacitidine (AZA)"},{"description":"CCRs included:\n\n* 1 Intensive Chemotherapy: Cytarabine 100-200 mg/m2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m² QD or Idarubicin 9-12 mg/m² 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\n* 2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC\n* 3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help","id":"FG001","title":"Conventional Care Regimens (CCR)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"89"},{"groupId":"FG001","numSubjects":"66"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"21"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"48"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"53"},{"groupId":"FG001","numSubjects":"58"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"39"}],"type":"Miscellaneous"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"241"},{"groupId":"FG001","numSubjects":"247"}],"type":"STARTED"},{"achievements":[{"comment":"5 patients not treated with any drug regimen","groupId":"FG000","numSubjects":"236"},{"comment":"7 patients not treated with any drug regimen","groupId":"FG001","numSubjects":"240"}],"type":"Treated Population"},{"achievements":[{"comment":"Received at least one dose of study medication and had at least 1 post dose safety assessment","groupId":"FG000","numSubjects":"236"},{"comment":"Received at least one dose of study medication and had at least 1 post dose safety assessment","groupId":"FG001","numSubjects":"235"}],"type":"Safety Population"},{"achievements":[{"comment":"Did not meet criteria for exclusion, received ≥1 cycle of treatment and had ≥ 1 efficacy assessment","groupId":"FG000","numSubjects":"179"},{"comment":"Did not meet criteria for exclusion, received ≥1 cycle of treatment and had ≥ 1 efficacy assessment","groupId":"FG001","numSubjects":"191"}],"type":"Evaluable Population"},{"achievements":[{"comment":"Participants who were continuing study treatment at the time of study closure","groupId":"FG000","numSubjects":"24"},{"comment":"Participants who were continuing study treatment at the time of study closure","groupId":"FG001","numSubjects":"13"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"217"},{"groupId":"FG001","numSubjects":"234"}],"type":"NOT COMPLETED"}],"title":"Treatment Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"8"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"116"},{"groupId":"FG001","numSubjects":"124"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}],"type":"Alive at study closure"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"140"},{"groupId":"FG001","numSubjects":"163"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"27"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"124"},{"groupId":"FG001","numSubjects":"136"}],"type":"NOT COMPLETED"}],"title":"Survival Follow-Up Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"0"}],"type":"Disease Progression"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"}],"milestones":[{"achievements":[{"comment":"2 participants did not enroll in the extension period.","groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"comment":"Participants who enrolled in the extension phase","groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"0"}],"type":"Safety Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Extension Phase"}],"recruitmentDetails":"This was a multicenter, international Phase 3 study conducted at 107 investigational sites in 18 countries including South Korea, China, Taiwan, Australia, Canada, United States, Poland, Russia, Czech Republic, Israel, France, Italy, Spain, Germany, United Kingdom, Belgium, Austria and the Netherlands."}