{"description":"3\\) discontinuation for BSC only. Median duration was 191.5, 65.0, 125.0, 124.5 and 360.0 days for each group respectively.\n\nAEs reported for the Azacitidine group are those that occurred in the treatment phase, AEs reported in the Azacitidine extension group occurred during extension phase","eventGroups":[{"description":"Azacitidine 75 mg/m\\^2/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":"EG000","otherNumAffected":226,"otherNumAtRisk":236,"seriousNumAffected":188,"seriousNumAtRisk":236,"title":"Azacitidine"},{"description":"Transfusion of blood products, antibiotics, antifungals and nutritional help","id":"EG001","otherNumAffected":33,"otherNumAtRisk":40,"seriousNumAffected":30,"seriousNumAtRisk":40,"title":"BSC Only"},{"description":"Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC","id":"EG002","otherNumAffected":151,"otherNumAtRisk":153,"seriousNumAffected":118,"seriousNumAtRisk":153,"title":"Low-dose Cytarabine"},{"description":"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","id":"EG003","otherNumAffected":42,"otherNumAtRisk":42,"seriousNumAffected":27,"seriousNumAtRisk":42,"title":"Intensive Chemotherapy"},{"description":"Azacitidine 75 mg/m\\^2/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":"EG004","otherNumAffected":18,"otherNumAtRisk":22,"seriousNumAffected":10,"seriousNumAtRisk":22,"title":"Azacitidine-extension"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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16.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":236},{"groupId":"EG001","numAffected":2,"numAtRisk":40},{"groupId":"EG002","numAffected":11,"numAtRisk":153},{"groupId":"EG003","numAffected":0,"numAtRisk":42},{"groupId":"EG004","numAffected":0,"numAtRisk":22}],"term":"LEUKOCYTOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 16.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":236},{"groupId":"EG001","numAffected":0,"numAtRisk":40},{"groupId":"EG002","numAffected":15,"numAtRisk":153},{"groupId":"EG003","numAffected":6,"numAtRisk":42},{"groupId":"EG004","numAffected":1,"numAtRisk":22}],"term":"LEUKOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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Median duration was 191.5, 65.0, 125.0, 124.5 and 360.0 days for each group respectively"}