{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"211","value":"1070"},{"comment":"Based on pre-specified criteria, statistical analysis was not performed if fewer than 3 participants have reportable parameter values. Individual AUCtau values are 276 and 879 ng\\*hr/mL.","groupId":"OG001","spread":"NA","value":"NA"}]}],"title":"Cytarabine"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"32","value":"28420"},{"comment":"Based on pre-specified criteria, statistical analysis was not performed if fewer than 3 participants have reportable parameter values. Individual AUCtau values are 32430 and 45900 ng\\*hr/mL.","groupId":"OG001","spread":"NA","value":"NA"}]}],"title":"Ara-U"}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"description":"Ara-U is the major metabolite of cytarabine. LDAC (low dose cytarabine) is rapidly degraded to the stable metabolite Ara-U, levels of both cytarabine and Ara-U were reported.","dispersionType":"Geometric Coefficient of Variation","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 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":"OG001","title":"Phase 1B: Glasdegib 200 mg + Cytarabine/Daunorubicin"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"PK parameter analysis set: all treated participants who had at least 1 of the PK parameters of interest for any of the study drugs.","reportingStatus":"POSTED","timeFrame":"Pre-dose, 6 and 24 hours post start of cytarabine infusion on Induction Cycle 1/Day 3","title":"AUCtau of Cytarabine and Ara-U in Participants Receiving Glasdegib and Cytarabine/Daunorubicin at Phase 1B on Induction Cycle 1/Day 3","type":"SECONDARY","unitOfMeasure":"ng*hr/mL"}