{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"16"},{"groupId":"OG005","value":"6"}]}],"title":"AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"10"},{"groupId":"OG005","value":"3"}]}],"title":"SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"16"},{"groupId":"OG005","value":"6"}],"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. An serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect.","groups":[{"description":"Participants received oral doses of glasdegib (PF-04449913) tablets 100 milligram (mg) starting on Day 3 of Cycle 1 for pharmacokinetic (PK) assessment purposes and thereafter once daily (QD) and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously twice daily (BID) on Days 1-10 of the 28-day cycles.","id":"OG000","title":"Phase 1B: Glasdegib 100 mg + LDAC"},{"description":"Participants received oral doses of glasdegib tablets 200 mg starting on Day 3 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28-day cycles. In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 2/Day 1 and Cycle 2/Day 16, respectively.","id":"OG001","title":"Phase 1B: Glasdegib 200 mg + LDAC"},{"description":"Participants received oral doses of glasdegib tablets 100 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m\\^2 as an intravenous (IV) infusion over 1 hour on Days 1-5 of the 28-day cycles.","id":"OG002","title":"Phase 1B: Glasdegib 100 mg + Decitabine"},{"description":"Participants received oral doses of glasdegib tablets 200 mg starting on Day 2 of Cycle 1 for PK assessment purposes and thereafter QD and continuously for 28-day cycles (starting on Day 1 for all other cycles). Decitabine was given at a dose of 20 mg/m\\^2 as an IV infusion over 1 hour on Days 1-5 of the 28-day cycles.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg. Participants who had glasdegib dose reduction were reported as the starting glasdegib dose level received. Two (2) participants in this cohort had dose reduction to 100 mg starting from Cycle 1/Day 24 and Cycle 5/Day 1, respectively.","id":"OG003","title":"Phase 1B: Glasdegib 200 mg + Decitabine"},{"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":"OG004","title":"Phase 1B: Glasdegib 100 mg + Cytarabine/Daunorubicin"},{"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 200 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.In March 2013, all active participants receiving glasdegib 200 mg were required to reduce dose to 100 mg.One (1) participant in this cohort had dose reduction to 100 mg starting from Consolidation Cycle 1/Day 21.","id":"OG005","title":"Phase 1B: Glasdegib 200 mg + 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 Categorized by Seriousness at Phase 1B","type":"SECONDARY","unitOfMeasure":"Participants"}