{"groups":[{"description":"Azacitidine 75 mg/m\\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).","id":"FG000","title":"Azacitidine 75 mg/m^2"},{"description":"Azacitidine 75 mg/m\\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).","id":"FG001","title":"Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"8"}],"type":"Site Terminated by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Reason not Specified"},{"reasons":[{"groupId":"FG000","numSubjects":"50"},{"groupId":"FG001","numSubjects":"47"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"62"},{"groupId":"FG001","numSubjects":"58"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"53"},{"groupId":"FG001","numSubjects":"55"}],"comment":"Response Evaluable Population (REP) included all participants who received at least 1 dose of study drug, have a disease assessment at baseline, and at least 1 post baseline disease assessment.","type":"Response Evaluable Population (REP)"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"62"},{"groupId":"FG001","numSubjects":"58"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants diagnosed with myelomonocytic, and myelogenous leukemia were randomized into two groups in 1:1 ratio to receive single-agent azacitidine or azacitidine + pevonedistat.","recruitmentDetails":"Participants took part in the study at 45 investigative sites in the United States \\[US\\], Canada, Belgium, Bulgaria, Czech Republic, Germany, France, Israel, Italy, Spain, and Ireland from 14 April 2016 to 23 July 2021."}