{"analyses":[{"ciLowerLimit":"-13.72","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.39","groupDescription":"Number of Participants with OR","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.329","pValueComment":"P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by low-blast AML, Revised International Prognostic Scoring System (IPSS-R) risk groups of very high, high, or intermediate for HR MDS/CMML.","paramType":"Absolute Rate Difference","paramValue":"-4.67","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"64"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"206"},{"groupId":"OG001","value":"208"}],"units":"Participants"}],"description":"Disease responses for HR MDS/CMML based on Modified IWG Response Criteria for MDS; for low-blast AML on Revised IWG Response Criteria for AML. Overall response=CR or PR for HR MDS/CMML and CR + CRi + PR for low-blast AML. CR for HR MDS/CMML: \\<=5% myeloblasts with normal maturation of all bone marrow cell lines, \\>=11 g/dL Hgb, \\>=100\\*10\\^9/L pl, \\>=1.0\\*10\\^9/L neutrophils, 0% blasts in peripheral blood and PR: all CR criteria met except bone marrow blasts \\>=50% decrease over pretreatment but still\\>5%. For low-blast AML-CR:morphologic leukemia-free state\\>1.0\\*10\\^9 neutrophils, \\>=100\\*10\\^9/L pl, transfusion independence, no residual evidence of extramedullary leukemia; CR with incomplete blood count recovery (CRi): fulfill CR criteria except residual neutropenia \\<1.0\\*10\\^9/L or pl \\<100\\*10\\^9/L; PR: all CR hematological values but \\>=50% decrease in bone marrow aspirate.","groups":[{"description":"Participants were administered azacitidine 75 mg/m\\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.","id":"OG000","title":"Azacitidine 75 mg/m^2"},{"description":"Participants were administered azacitidine 75 mg/m\\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.","id":"OG001","title":"Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 postbaseline disease assessment.","reportingStatus":"POSTED","timeFrame":"From randomization until CR and PR or CR, CRi and PR (up to approximately 42 months)","title":"Number of Participants With Overall Response (OR)","type":"SECONDARY","unitOfMeasure":"Participants"}