{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]}],"title":"Grade 1 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"}]}],"title":"Grade 2 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"8"}]}],"title":"Grade 3 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"15"}]}],"title":"Grade 4 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"17"}]}],"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":"69"},{"groupId":"OG001","value":"84"},{"groupId":"OG002","value":"41"}],"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. 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":"Participants received 1-2 cycles of induction (glasdegib and daunorubicin/cytarabine), followed by 2-4 cycles of consolidation (glasdegib and high dose cytarabine) and a maximum of 6 cycles of maintenance (glasdegib alone). Daunorubicin was given on Days 1-3 QD at a dose of 60 mg/m\\^2/day by IV together with cytarabine on Days 1-7 at a dose of 100 mg/m\\^2/day by continuous IV infusion for each cycle of induction. Cytarabine was given on Days 1, 3, and 5 at a dose of 1 g/m\\^2 administered as a 3-hour IV infusion every 12 hours (2 g/m\\^2/day) for each cycle of consolidation. Glasdegib tablets 100 mg QD was started on induction Cycle 1/Day -3 and administered continuously QD thereafter for the duration of the study. A cycle was defined as 28 days.","id":"OG000","title":"Phase 2 Fit: Glasdegib 100 mg + Cytarabine/Daunorubicin"},{"description":"Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.","id":"OG001","title":"Phase 2 Unfit: Glasdegib 100 mg + LDAC"},{"description":"Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.","id":"OG002","title":"Phase 2 Unfit: LDAC Alone"}],"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 2 Fit and Unfit (All Causality)","type":"SECONDARY","unitOfMeasure":"Participants"}