{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"All-causality TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}],"title":"Treatment-related TEAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"Maximum Grade 3 or 4 TEAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"}],"description":"An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. TEAEs were AEs that occurred after initiation of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. Grades of AEs were defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE.","groups":[{"description":"Participants received SC administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit DDI evaluation.","id":"OG000","title":"Lead-in Cohort"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety analysis population included all participants who received at least 1 dose of any study treatment.","reportingStatus":"POSTED","timeFrame":"maximum of approximately 15 months","title":"Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Lead-in Cohort (LIC)","type":"PRIMARY","unitOfMeasure":"Participants"}