Number of Participants With Adverse Events (AEs)

Azacitidine (AZA)

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.

Conventional Care Regimen #3 Best Supportive Care Only

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.

Conventional Care Regimen #2 Low-dose Cytarabine

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.

Conventional Care Regimen #1 Intensive Chemotherapy

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.

Analysis denominator · Participants