{"analyses":[{"ciLowerLimit":"-13.95","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.68","groupDescription":"Overall Response for HR MDS/CMML","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.261","pValueComment":"P-value was obtained from a stratified Cochran-Mantel-Haenszel chi-square test stratified by IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.","paramType":"Absolute Rate Difference","paramValue":"-5.14","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"3.22","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"41.49","groupDescription":"Overall Response for Low-blast AML","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.026","pValueComment":"P-value was obtained from an unstratified Cochran-Mantel-Haenszel chi-square test.","paramType":"Absolute Rate Difference","paramValue":"22.36","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"29"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"157"},{"groupId":"OG001","value":"163"}],"units":"Participants"}],"title":"Overall Response for HR MDS/CMML"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"22"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"45"}],"units":"Participants"}],"title":"Overall Response for Low-blast AML"}],"denoms":[{"counts":[{"groupId":"OG000","value":"206"},{"groupId":"OG001","value":"208"}],"units":"Participants"}],"description":"Responses for HR MDS/CMML are based on Modified International Working Group (IWG) Response Criteria for MDS and for low-blast AML on Revised IWG Response Criteria for AML. Overall response=CR and PR for HR MDS/CMML and CR+CR with incomplete blood count recovery(CRi)+PR for low-blast AML. CR for HR MDS/CMML:\\<=5% myeloblasts with normal maturation of all bone marrow cell lines,\\>=11g/dL hemoglobin (Hgb),\\>=100\\*10\\^9/L platelet (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;CRi:fulfill CR criteria except residual neutropenia \\<1.0\\*10\\^9/L/thrombocytopenia (pl\\<100\\*10\\^9/L); PR:all CR hematological values but\\>=50% decrease in percentage of blasts to 5%-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":"REP included all participants who received at least 1 dose of study drug and had a Baseline and at least 1 post-baseline disease assessment. Number analyzed is the number of participants with data available for analysis for the specified category.","reportingStatus":"POSTED","timeFrame":"Up to Cycle 6 (up to approximately Day 168)","title":"Number of Participants With Overall Response by Cycle 6","type":"SECONDARY","unitOfMeasure":"Participants"}