{"analyses":[{"ciLowerLimit":"0.542","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.458","estimateComment":"Hazard ratio was based on an unadjusted stratified Cox proportional hazard regression model with stratification factors (low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML) and treatment as a factor in the model.","groupDescription":"Duration of Overall Response (OR)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.320","pValueComment":"P-value comparing duration of PR or better response between treatment groups was based on 1-sided log-rank test stratified by low-blast AML, IPSS-R risk groups of very high, high, or intermediate for HR MDS/CMML.","paramType":"Hazard Ratio (HR)","paramValue":"0.889","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The upper limit of 95% CI was not estimable due to low number of participants with event.","groupId":"OG000","lowerLimit":"8.31","upperLimit":"NA","value":"18.3"},{"comment":"The upper limit of 95% CI was not estimable due to low number of participants with event.","groupId":"OG001","lowerLimit":"12.68","upperLimit":"NA","value":"17.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"64"}],"units":"Participants"}],"description":"Duration of OR: response to first documentation of PD or relapse from CR for low-blast AML or relapse after CR or PR for HR MDS/CMML. 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 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 % of blasts in bone marrow aspirate.","dispersionType":"95% Confidence Interval","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":"MEDIAN","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. Data is reported for responders.","reportingStatus":"POSTED","timeFrame":"Up to approximately 42 months","title":"Duration of Overall Response (OR)","type":"SECONDARY","unitOfMeasure":"months"}