{"groups":[{"description":"Participants received 300 mg oral azacitidine tablets daily (QD) on days 1 to 21 of each 28-day treatment cycle and best supportive care (BSC) which included and was not limited to packed RBC (packed red blood cell \\[pRBC\\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.","id":"FG000","title":"Oral Azacitidine Plus Best Supportive Care"},{"description":"Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.","id":"FG001","title":"Placebo Plus Best Supportive Care"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"79"},{"groupId":"FG001","numSubjects":"86"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"12"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"8"}],"type":"Other reasons"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"107"},{"groupId":"FG001","numSubjects":"109"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Ongoing treatment","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"107"},{"groupId":"FG001","numSubjects":"109"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants were stratified by: average baseline (BL) Red Blood Cell (RBC) transfusion requirement (≤ 4 units versus \\> 4 units of RBC per 28 days), BL platelet transfusion status (dependent or independent), country of enrollment and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 to 1 versus 2).","recruitmentDetails":"Participants were randomized at 101 sites globally. The sites were located in: Europe (76), North America (13), Asia/Pacific (10), and Latin America (2). Results are reported as of the data cut-off date of 25 January 2019."}