{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"57"}]}],"title":"TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"40"}]}],"title":"SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"58"}],"units":"Participants"}],"description":"An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is an medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. A TEAE was defined as any adverse event occurring after the start of pevonedistat administration of the treatment period.","groups":[{"description":"Azacitidine 75 milligram per square meter (mg/m\\^2), infusion, intravenously or subcutaneously, on Days 1 to 5, and on 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":"OG000","title":"Azacitidine 75 mg/m^2"},{"description":"Azacitidine 75 mg/m\\^2, infusion, intravenously or subcutaneously, on Days 1 to 5, and on 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":"OG001","title":"Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Population included all enrolled participants who receive at least 1 dose of any study drug azacitidine alone or pevonedistat + azacitidine.","reportingStatus":"POSTED","timeFrame":"From date of first dose up to 30 days after administration of the last dose of any study drug (up to approximately 5 years)","title":"Number of Participants Reporting One or More Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}