{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"}]}],"title":"Treatment emergent SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"Treatment related SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"description":"A SAE was defined as any untoward medical occurrence that, at any dose that resulted in death; was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect or other medical events as per investigator's judgement. A SAE was considered treatment emergent if the event occurred during the on-treatment period (regardless of if it was seen prior to the start of treatment). A SAE was considered treatment related as assigned by the investigator.","groups":[{"description":"Participants received glasdegib 100 milligrams (mg) tablet per oral (PO) once a day (QD) in combination with azacitidine 75 mg per meter squared (m\\^2)/day as subcutaneous (SC) injection or intravenous (IV) infusion for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment.","id":"OG000","title":"Glasdegib + Azacitidine"},{"description":"Participants received placebo matched to Glasdegib in combination with azacitidine 75mg/m\\^2/day SC or IV for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment.","id":"OG001","title":"Placebo + Azacitidine"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety analysis set included all participants who receive at least one dose of study treatment.","reportingStatus":"POSTED","timeFrame":"From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days)","title":"Number of Participants With Treatment Emergent Serious Adverse Events (SAE) and Treatment Related SAEs","type":"PRIMARY","unitOfMeasure":"Participants"}