{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"}]}],"title":"Grade 1 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"7"}]}],"title":"Grade 2 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"}]}],"title":"Grade 3 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"10"}]}],"title":"Grade 4 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Grade 5 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Missing or unknown AEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"22"}],"units":"Participants"}],"description":"An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not necessarily had a causal relationship with the treatment or usage. Treatment Emergent AEs were those with initial onset or increasing in severity after the first dose of study medication and occurred within 28 days post last dose. Treatment-related AEs were AEs related to glasdegib and/or backbone chemotherapy. AEs were graded by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 : Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE.","groups":[{"description":"Included all participants who received oral glasdegib in combination with LDAC in phase 1B portion.","id":"OG000","title":"Phase 1B: Glasdegib + LDAC"},{"description":"Included all participants who received oral glasdegib in combination with decitabine in phase 1B portion.","id":"OG001","title":"Phase 1B: Glasdegib + Decitabine"},{"description":"Included all participants who received oral glasdegib in combination with cytarabine/daunorubicin in phase 1B portion.","id":"OG002","title":"Phase 1B: Glasdegib + Cytarabine/Daunorubicin"}],"paramType":"NUMBER","populationDescription":"Safety analysis set: all enrolled participants who received at least 1 dose of any of the study medications for each drug combination.","reportingStatus":"POSTED","timeFrame":"4 years","title":"Number of Participants With Treatment-emergent AEs at Phase 1B (Treatment-related)","type":"SECONDARY","unitOfMeasure":"Participants"}