{"analyses":[{"ciLowerLimit":"-19.44","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"13.75","groupDescription":"OR: HR MDS/CMML Participants","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.683","pValueComment":"P-value for HR MDS/CMML was obtained from a stratified Cochran-Mantel-Haenszel chi-square test","paramType":"Absolute Rate Difference","paramValue":"-2.85","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"-20.39","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"25.12","groupDescription":"ORR: Low-blast AML Participants","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.840","pValueComment":"P-value for Low-blast AML was obtained from an unstratified Cochran-Mantel-Haenszel chi-square test.","paramType":"Absolute Rate Difference","paramValue":"2.36","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"13"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"54"}],"units":"Participants"}],"title":"OR: HR MDS/CMML Participants"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"12"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"32"}],"units":"Participants"}],"title":"OR: Low-blast AML Participants"}],"denoms":[{"counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"54"}],"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 + 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 the percentage of blasts to 5% to 25% 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":"ITT Population included all participants who were randomized. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis for the specified category.","reportingStatus":"POSTED","timeFrame":"From randomization until CR, CRi and PR (up to approximately 42 months)","title":"Number of Participants With Overall Response in Participants Who Have TP53 Mutations, 17p Deletions, and/or Are Determined to be in an Adverse Cytogenetic Risk Group","type":"SECONDARY","unitOfMeasure":"Participants"}