Trial Outcomes & Findings for A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia (NCT NCT03416179)

Last Updated: 2023-04-21

Results Overview

OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

730 participants

Primary outcome timeframe

Baseline up to 25 months

Results posted on

2023-04-21

Participant Flow

This study evaluated glasdegib in intensive and non-intensive chemotherapy populations. Intensive study: Glasdegib was studied in combination with cytarabine and daunorubicin for the treatment of adult participants with previously untreated acute myeloid leukemia (AML). Non-intensive study: Glasdegib was studied in combination with azacitidine for the treatment of adult participants with previously untreated AML who were not candidates for intensive induction chemotherapy.

Inadvertently 1 participant was enrolled twice into the study resulting in enrollment number as 730. However, a total of 729 participants were randomized and received treatment in the study. Although participation of participants was terminated by the sponsor, the study was considered completed as participants were fully enrolled as planned.

Participant milestones

Participant milestones
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 milligram per square meter (mg/m\^2) daily by intravenous (IV) infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with less than (\<) 5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram per square meter (gm/m\^2) IV for adults greater than or equals to (\>=) 60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received hematopoietic stem cell transplantation (HSCT) per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 milligram (mg) tablet orally (PO) once daily (QD) from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive complete remission (CR) minimal residual disease (MRD)-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).	Non-intensive Study: Glasdegib + Azacitidine Participants received chemotherapy with azacitidine 75 mg/m\^2 SC injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participant refusal or death, whichever occurred first. Participants also were to receive glasdegib 100 mg PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib unless 2 consecutive negative MRD assessments (3 year).	Non-intensive Study: Placebo + Azacitidine Participants received chemotherapy with azacitidine 75 mg/m\^2 SC injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participants refusal or death, whichever occurred first. Participants also received glasdegib 100 mg tablet matching placebo PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib matching placebo unless 2 consecutive negative MRD assessments (2.44 year).
Overall Study STARTED	201	203	163	162
Overall Study Treated	198	201	162	160
Overall Study COMPLETED	0	1	13	6
Overall Study NOT COMPLETED	201	202	150	156

Reasons for withdrawal

Reasons for withdrawal
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 milligram per square meter (mg/m\^2) daily by intravenous (IV) infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with less than (\<) 5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram per square meter (gm/m\^2) IV for adults greater than or equals to (\>=) 60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received hematopoietic stem cell transplantation (HSCT) per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 milligram (mg) tablet orally (PO) once daily (QD) from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive complete remission (CR) minimal residual disease (MRD)-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).	Non-intensive Study: Glasdegib + Azacitidine Participants received chemotherapy with azacitidine 75 mg/m\^2 SC injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participant refusal or death, whichever occurred first. Participants also were to receive glasdegib 100 mg PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib unless 2 consecutive negative MRD assessments (3 year).	Non-intensive Study: Placebo + Azacitidine Participants received chemotherapy with azacitidine 75 mg/m\^2 SC injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participants refusal or death, whichever occurred first. Participants also received glasdegib 100 mg tablet matching placebo PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib matching placebo unless 2 consecutive negative MRD assessments (2.44 year).
Overall Study Death	90	87	117	113
Overall Study Withdrawal by Subject	15	20	6	9
Overall Study Lost to Follow-up	1	1	0	3
Overall Study Study participation terminated by Sponsor	93	91	26	31
Overall Study Other	2	3	1	0

Baseline Characteristics

A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=201 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=203 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).	Non-intensive Study: Glasdegib + Azacitidine n=163 Participants Participants received chemotherapy with azacitidine 75 mg/m\^2 SC injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participant refusal or death, whichever occurred first. Participants also were to receive glasdegib 100 mg PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib unless 2 consecutive negative MRD assessments (3 year).	Non-intensive Study: Placebo + Azacitidine n=162 Participants Participants received chemotherapy with azacitidine 75 mg/m\^2 SC injection or IV infusion from Day 1 up to Day 7 of each cycle (28 day) and continued for at least 6 cycles or until unacceptable toxicity, participants refusal or death, whichever occurred first. Participants also received glasdegib 100 mg tablet matching placebo PO QD from Day 1 of chemotherapy until clinical benefit or disease progression, unacceptable toxicity, consent withdrawal, or death, whichever occurred first. Eligible participants underwent HSCT per local standard of care and were to receive glasdegib matching placebo unless 2 consecutive negative MRD assessments (2.44 year).	Total n=729 Participants Total of all reporting groups
Age, Continuous	56.55 years STANDARD_DEVIATION 12.60 • n=5 Participants	55.38 years STANDARD_DEVIATION 13.61 • n=7 Participants	73.19 years STANDARD_DEVIATION 7.17 • n=5 Participants	73.14 years STANDARD_DEVIATION 6.82 • n=4 Participants	63.63 years STANDARD_DEVIATION 13.79 • n=21 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	97 Participants n=7 Participants	97 Participants n=5 Participants	89 Participants n=4 Participants	354 Participants n=21 Participants
Sex: Female, Male Male	130 Participants n=5 Participants	106 Participants n=7 Participants	66 Participants n=5 Participants	73 Participants n=4 Participants	375 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	16 Participants n=4 Participants	59 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	166 Participants n=5 Participants	171 Participants n=7 Participants	140 Participants n=5 Participants	139 Participants n=4 Participants	616 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	20 Participants n=7 Participants	11 Participants n=5 Participants	7 Participants n=4 Participants	54 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	66 Participants n=5 Participants	57 Participants n=7 Participants	51 Participants n=5 Participants	44 Participants n=4 Participants	218 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants	14 Participants n=21 Participants
Race (NIH/OMB) White	110 Participants n=5 Participants	123 Participants n=7 Participants	97 Participants n=5 Participants	99 Participants n=4 Participants	429 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	20 Participants n=7 Participants	14 Participants n=5 Participants	12 Participants n=4 Participants	66 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline up to 25 months

Population: FA set included all randomized participants.

OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=201 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=203 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Intensive Study: Overall Survival (OS)	17.3 months Interval 15.2 to 18.5	20.4 months Interval 17.6 to Upper limit of 95 % CI was not estimable due to low number of participants with events.

PRIMARY outcome

Timeframe: Baseline up to 25 months

Population: FA set included all randomized participants.

OS is defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were to be censored at the date of last contact.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=163 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=162 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Overall Survival (OS)	10.3 months Interval 7.7 to 12.4	10.6 months Interval 8.4 to 13.3

SECONDARY outcome

Timeframe: Post-baseline up to Week 8

Population: FA set included all randomized participants.

MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). "Fatigue" was measured at the participants' worst level in last 24 hours by asking participants to respond to each item on an 0-10 numeric rating scale (NRS), where 0 = "not present" and 10 = "as bad as you can imagine". Percentage of participants who had improvement in "fatigue" symptoms reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=201 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=203 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MD Anderson Symptom Inventory -Acute Myelogenous Leukemia/Myelodysplastic Syndrome (MDASI-AML/MDS) Questionnaire	17.41 Percentage of participants Interval 12.17 to 22.66	17.24 Percentage of participants Interval 12.05 to 22.44

SECONDARY outcome

Timeframe: Post-baseline up to Week 12

Population: FA set included all randomized participants.

MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). "Fatigue" was measured at the participants' worst level in last 24 hours by asking participants to respond to each item on an 0-10 NRS, where 0 = "not present" and 10 = "as bad as you can imagine". Percentage of participants who had improvement in "fatigue" symptoms reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=163 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=162 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Percentage of Participants Who Improved in Fatigue Score Measured by the MDASI-AML/MDS Questionnaire at Week 12	11.66 Percentage of participants Interval 6.73 to 16.58	15.43 Percentage of participants Interval 9.87 to 21.0

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Population: FA set included all randomized participants.

Complete remission (CR) was defined based on 2017 European LeukemiaNet (ELN) recommendations. CR: Bone marrow blasts \<5 percentage (%); absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC) greater than equal to (\>=) 1.0\*10\^9/Liter (L); platelet count \>=100\*10\^9/L. CRMRD-neg: CR with negativity for a genetic marker by reverse transcription quantitative polymerase chain reaction (RT-qPCR), or CR with negativity by Multiparameter Flow Cytometry (MFC).

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=201 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=203 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg)	5.0 Percentage of participants Interval 2.4 to 9.0	5.4 Percentage of participants Interval 2.7 to 9.5

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Population: FA set included all randomized participants.

CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRMRDneg: CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=163 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=162 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Percentage of Participants With Complete Remission Without Negative Minimal Residual Disease (CRMRD-neg)	1.8 Percentage of participants Interval 0.4 to 5.3	0.6 Percentage of participants Interval 0.0 to 3.4

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Population: FA set included all randomized participants.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=201 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=203 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Intensive Study: Percentage of Participants With Complete Remission Including Negative Minimal Residual Disease (CRMRD-neg)	49.3 Percentage of participants Interval 42.1 to 56.4	47.3 Percentage of participants Interval 40.3 to 54.4

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Population: FA set included all randomized participants.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=163 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=162 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Percentage of Participants With Complete Remission (CR) Including Negative Minimal Residual Disease (CRMRD-neg)	19.6 Percentage of participants Interval 13.8 to 26.6	13.0 Percentage of participants Interval 8.2 to 19.1

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Population: FA set included all randomized participants.

CR was defined based on 2017 ELN recommendations. CR: MRD (positive or unknown), bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC less than (\<) 1.0\*10\^9/L; platelet count \<100 × 10\^9/L. CRi (included CR \[includes CRMRD-neg\]): not qualifying for CR, neutropenia \<1.0\*10\^9/L or platelets \<100\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=201 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=203 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi)	1.5 Percentage of participants Interval 0.3 to 4.3	5.4 Percentage of participants Interval 2.7 to 9.5

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Population: FA set included all randomized participants.

CR was defined based on 2017 ELN recommendations. CR: MRD (positive or unknown), bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \<1.0\*10\^9/L; platelet count \<100 × 10\^9/L. CRi (included CR \[includes CRMRD-neg\]): not qualifying for CR, neutrophil \<0.5\*10\^9/L or platelets \<50\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=163 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=162 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Percentage of Participants With Complete Remission With Incomplete Hematologic Recovery (CRi)	2.5 Percentage of participants Interval 0.7 to 6.2	4.9 Percentage of participants Interval 2.2 to 9.5

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Population: FA set included all randomized participants.

MLFS was defined based on 2017 ELN recommendations. MLFS: MRD (positive or unknown), bone marrow blasts \<5%, no hematologic recovery required, marrow should not be aplastic, at least 200 cells enumerated or cellularity absence of extramedullary disease \>=10%, and absence of blasts with Auer rods.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=201 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=203 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS)	1.5 Percentage of participants Interval 0.3 to 4.3	2.0 Percentage of participants Interval 0.5 to 5.0

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Population: FA set included all randomized participants.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=163 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=162 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Percentage of Participants With Morphologic Leukemia-free State (MLFS)	3.1 Percentage of participants Interval 1.0 to 7.0	0.6 Percentage of participants Interval 0.0 to 3.4

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Population: FA set included all randomized participants.

PR was defined based on 2017 ELN recommendations. PR: MRD (positive or unknown); bone marrow blasts - decrease to 5-25% and decrease of pre-treatment bone marrow blast percentage by at least 50%; neutrophil count \>=1.0\*10\^9/L; and platelets count \>=100\*10\^9/L.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=201 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=203 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Intensive Study: Percentage of Participants With Partial Remission (PR)	5.0 Percentage of participants Interval 2.4 to 9.0	4.4 Percentage of participants Interval 2.0 to 8.2

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Population: FA set included all randomized participants.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=163 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=162 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Percentage of Participants With Partial Remission (PR)	2.5 Percentage of participants Interval 0.7 to 6.2	4.9 Percentage of participants Interval 2.2 to 9.5

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Population: FA set included all randomized participants. This outcome measure was planned to be analyzed only in non-intensive study.

CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\*10\^9/L and platelets \>=50\*10\^9/L must be met, but does not satisfy both neutrophils \>=1\*10\^9/L and platelets \>=100\*10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=163 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=162 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Percentage of Participants With Complete Remission With Partial Hematologic Recovery (CRh)	3.1 Percentage of participants Interval 1.0 to 7.0	3.1 Percentage of participants Interval 1.0 to 7.1

SECONDARY outcome

Timeframe: From date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause (maximum up to 2 years)

Population: The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, DORi was not collected, analyzed and reported.

DoRi: only defined for participants who have ever achieved CRi or better (included CR as well) on study as the time from date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause. CRi: not qualifying for CR, neutropenia \<1.0\*10\^9/L or platelets \<100\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5 %; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. Participants last known to be alive who were free from relapse after CRi or better were censored at the date of last disease assessment that verifies their status.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of first achieving CRi/CRh or better to the date of relapse/disease progression after CRi/CRh or better or death due to any cause (maximum up to 3 years)

Population: The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, DORi and DoRh was not collected, analyzed and reported.

DoRi: only defined for participants who have ever achieved CRi or better (included CR and CRh) on study as the time from date of first achieving CRi or better to the date of relapse after CRi or better or death due to any cause. DoRh: participants who had ever achieved CRh or better (included CR) on study as the time from date of first achieving CRh or better to the date of disease progression, or relapse after CRh or better, or death due to any cause. CRi: not qualifying for CR, neutrophil \<0.5\*10\^9/L or platelets \<50\*10\^9, absence of extramedullary disease, and absence of blasts with Auer rods. CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\*10\^9/L and platelets \>=50\*10\^9/L must be met, but does not satisfy both neutrophils \>=1\*10\^9/L and platelets \>=100\*10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of randomization to the first documentation of response (CRi/CRh or better) (maximum up to 3 years)

Population: FA set included all randomized participants.

TTRi:Participants who achieved CRi or better, as the time from date of randomization to first documentation of response(CRi or better).TTRh:Participants who achieved CRh or better, as the time from date of randomization to first documentation of response(CRh or better). CRi:not qualifying for CR, neutrophil\<0.5\*10\^9/L or platelets\<50\*10\^9, absence of extramedullary disease,absence of blasts with Auer rods. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5 %; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L. CRh: MRD (positive or unknown); bone marrow blasts \<5%; assessed in non-intensive chemotherapy study only, not qualifying for CR, ie, both neutrophil \>=0.5\*10\^9/L and platelets \>=50\*10\^9/L must be met, but does not satisfy both neutrophils \>=1\*10\^9/L and platelets \>=100\*10\^9/L at the same time; absence of extramedullary disease; and absence of blasts with Auer rods.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=163 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=162 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Time to Response TTRi	4.057 Months Standard Deviation 1.9532	4.093 Months Standard Deviation 2.1809
Non-intensive Study: Time to Response TTRh	4.334 Months Standard Deviation 1.8853	4.146 Months Standard Deviation 2.1540

SECONDARY outcome

Timeframe: From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 2 years)

Population: The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, EFS was not collected, analyzed and reported.

EFS: Time from the date of randomization to the date of treatment failure (TF), relapse from CR, or death from any cause, whichever comes first. TF was defined as failure to achieve CR during the induction cycle (including the re-induction cycle if there is one) and the event date for TF is the day of randomization. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first (maximum up to 3 years)

Population: The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, EFS was not collected, analyzed and reported.

EFS: Time from the date of randomization to the date of TF, relapse from CR, or death from any cause, whichever comes first. TF was defined as failure to achieve CR during the induction cycle (including the re-induction cycle if there is one) and the event date for TF is the day of randomization. CR was defined based on 2017 ELN recommendations. CR: Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC \>=1.0\*10\^9/L; platelet count \>=100\*10\^9/L.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Population: The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, MDASI-AML/MDS was not collected, analyzed and reported.

MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). The 13 core symptoms and 6 core interference items had highest frequency and/or severity in participants with various cancers and treatment types. It was measured at severity of symptoms and related interference at their worst level in last 24 hours by asking participants to respond to each item on an 0-10 NRS, where 0 = "not present" or "did not interfere" and 10 = "worst" or "interfered completely".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Population: The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, MDASI-AML/MDS was not collected, analyzed and reported.

MDASI-AML/MDS: consists of 23 items, 13-item core cancer symptoms (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, problem remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness), 4-item AML/MDS specific symptoms (malaise, diarrhea, muscle weakness, and skin problems), and 6 areas of interference (general activity, mood, work, walking, relations with other people, and enjoyment of life). The 13 core symptoms and 6 core interference items had highest frequency and/or severity in participants with various cancers and treatment types. It was measured at severity of symptoms and related interference at their worst level in last 24 hours by asking participants to respond to each item on an 0-10 NRS, where 0 = "not present" or "did not interfere" and 10 = "worst" or "interfered completely".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Population: The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, EQ-5D-5L was not collected, analyzed and reported.

EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), the EuroQoL visual analogue scale (EQ-VAS). EQ-5D: descriptive system measures a participant's health state on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participant is asked to indicate his/her health state by rating each dimension on a 5-level scale (1=no problem, 5=extreme problem). This rating resulted in a 1-digit number expressing the level selected for that dimension. The digits for the 5 dimensions were combined in a 5-digit number describing the respondent's health state. The EQ-5D index scores ranges from 0 to 1, with 0=worst health state and 1=perfect health.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Population: The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, EQ-5D-5L was not collected, analyzed and reported.

EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL group. It consists of the EQ-5D descriptive system and a VAS, EQ-VAS. EQ-5D: descriptive system measures a participant's health state on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participant is asked to indicate his/her health state by rating each dimension on a 5-level scale (1=no problem, 5=extreme problem). This rating resulted in a 1-digit number expressing the level selected for that dimension. The digits for the 5 dimensions were combined in a 5-digit number describing the respondent's health state. The EQ-5D index scores ranges from 0 to 1, with 0=worst health state and 1=perfect health.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Population: The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, EQ-VAS was not collected, analyzed and reported.

EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL group. It consists of the EQ-5D descriptive system and a VAS, EQ-VAS. EQ VAS records the respondent's self-rated health on a 20-cm vertical, VAS from 0 (worst imaginable health state) to 100 (best imaginable health state).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Population: The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, EQ-VAS was not collected, analyzed and reported.

EQ-5D-5L: brief, self-administered, validated and reliable generic health status instrument developed by the EuroQoL group. It consists of the EQ-5D descriptive system and a VAS, EQ-VAS. EQ VAS records the respondent's self-rated health on a 20-cm vertical, VAS from 0 (worst imaginable health state) to 100 (best imaginable health state).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Population: The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, PGIS was not collected, analyzed and reported.

PGIS: is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time. It uses a 4-point Likert scale as follows: In the last 24 hours, symptoms are: 1-"absent (no symptoms)", 2-"mild", 3-" moderate", 4="severe".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Population: The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, PGIS was not collected, analyzed and reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Population: The intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, PGIC was not collected, analyzed and reported.

PGIC: a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 7-point Likert scale anchored by (1) 'very much improved' to (7) 'very much worse', with (4) =' no change'. The PGIC is a measure of "participant rating of global improvement and satisfaction with treatment".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Population: The non-intensive cohort was terminated because of futility. Participants ended study intervention early and were not followed up as planned. Hence, PGIC was not collected, analyzed and reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Population: Safety Analysis (SA) set included all participants who received at least one dose of study drug.

AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. AEs included SAEs and all non-SAEs. NCI CTCAE v.4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=198 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=201 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 AEs	196 Participants	198 Participants
Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 SAEs	86 Participants	92 Participants
Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 Grade 3 or 4 AE	173 Participants	169 Participants
Intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 Grade 5 AE	16 Participants	20 Participants

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Population: SA set included all participants who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=162 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=160 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 AEs	161 Participants	158 Participants
Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 SAEs	117 Participants	124 Participants
Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 Grade 3 or 4 AE	106 Participants	100 Participants
Non-intensive Study: Number of Participants With Adverse Events (AEs),Serious Adverse Events (SAEs) and According to Severity AEs Graded by NCI CTCAE v.4.03 Grade 5 AE	50 Participants	52 Participants

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Population: SA set included all participants who received at least one dose of study drug.

A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. NCI CTCAE v.4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=198 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=201 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 Treatment related AEs	181 Participants	188 Participants
Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 Treatment related SAEs	48 Participants	60 Participants
Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 Grade 3 or 4 AE	161 Participants	149 Participants
Intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 Grade 5 AE	5 Participants	8 Participants

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Population: SA set included all participants who received at least one dose of study drug.

A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. SAE: any AE, regardless of dose, that led to death; was life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant incapacity or led to congenital anomaly or birth defect. NCI CTCAE v4.03, Grade 3=severe adverse event, Grade 4= life threatening consequences; urgent intervention indicated, Grade 5= death related to adverse event.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=162 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=160 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 Treatment related AEs	133 Participants	123 Participants
Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 Treatment related SAEs	45 Participants	37 Participants
Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 Grade 3 or 4 AE	97 Participants	72 Participants
Non-intensive Study: Number of Participants With Treatment Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI CTCAE v.4.03 Grade 5 AE	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Population: SA set included all participants who received at least one dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specified rows.

Hematology laboratory test included: anemia, hemoglobin increased, international normalized ratio (INR) increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, and white blood cell decreased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for hematology laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=196 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=197 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Anemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	2 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Anemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	27 Participants	14 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Anemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	113 Participants	103 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Anemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	4 Participants	5 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Anemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	52 Participants	73 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hemoglobin increased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	2 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hemoglobin increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	194 Participants	194 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hemoglobin increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	2 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	3 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count decreased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	2 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	4 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	21 Participants	26 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	160 Participants	152 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	1 Participants	0 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	11 Participants	9 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count increased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	6 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	185 Participants	180 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	6 Participants	4 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count increased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	1 Participants	3 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count increased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	0 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Neutrophil count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	4 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Neutrophil count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	4 Participants	2 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Neutrophil count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	85 Participants	79 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Neutrophil count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	2 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Neutrophil count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	105 Participants	106 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Platelet count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	2 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Platelet count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	98 Participants	100 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Platelet count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	97 Participants	95 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 White blood cell decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	4 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 White blood cell decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	3 Participants	2 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 White blood cell decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	155 Participants	156 Participants
Intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 White blood cell decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	37 Participants	35 Participants

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Hematology laboratory test included: anemia, hemoglobin increased, INR increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, and white blood cell decreased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for hematology laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=162 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=160 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Anemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	29 Participants	41 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Anemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	97 Participants	87 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Anemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	5 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Anemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	29 Participants	31 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hemoglobin increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	160 Participants	159 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hemoglobin increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count decreased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	96 Participants	89 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	51 Participants	54 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	4 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	7 Participants	13 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count increased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	3 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	147 Participants	157 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	7 Participants	3 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Lymphocyte count increased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	2 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Neutrophil count decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	4 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Neutrophil count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	13 Participants	22 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Neutrophil count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	48 Participants	40 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Neutrophil count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Neutrophil count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	92 Participants	97 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Platelet count decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	21 Participants	28 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Platelet count decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	55 Participants	64 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Platelet count decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	1 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Platelet count decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	83 Participants	68 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 White blood cell decreased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	1 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 White blood cell decreased: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 White blood cell decreased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	43 Participants	48 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 White blood cell decreased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	70 Participants	62 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 White blood cell decreased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Hematological Laboratory Abnormalities Graded by NCI CTCAE v.4.03 White blood cell decreased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	45 Participants	48 Participants

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Chemistry laboratory test included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, chronic kidney disease, creatine phosphokinase (CPK) increased, creatinine increased, gamma glutamyl transferase (GGT) increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and hypophosphatemia. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for chemistry laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=196 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=198 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Alanine aminotransferase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	1 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Alanine aminotransferase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	175 Participants	184 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Alanine aminotransferase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	16 Participants	13 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Alanine aminotransferase increased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	1 Participants	0 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Alkaline phosphatase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	3 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Alkaline phosphatase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	187 Participants	192 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Alkaline phosphatase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	2 Participants	3 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Aspartate aminotransferase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	5 Participants	2 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Aspartate aminotransferase increased: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Aspartate aminotransferase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	173 Participants	186 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Aspartate aminotransferase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	15 Participants	9 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Blood bilirubin increased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	3 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Blood bilirubin increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	184 Participants	189 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Blood bilirubin increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	8 Participants	5 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Blood bilirubin increased: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Chronic kidney disease: Missing (baseline grade) to Grade <=2 (CTCAE grade)	4 Participants	5 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Chronic kidney disease: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	182 Participants	188 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Chronic kidney disease: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	8 Participants	4 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Chronic kidney disease: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	1 Participants	0 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Chronic kidney disease: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 CPK increased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	20 Participants	19 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 CPK increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	161 Participants	166 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 CPK increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	2 Participants	0 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Creatinine increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	188 Participants	192 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Creatinine increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	7 Participants	6 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 GGT increased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	5 Participants	7 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 GGT increased: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	8 Participants	11 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 GGT increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	2 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypercalcemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	1 Participants	5 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypercalcemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	191 Participants	192 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperglycemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	1 Participants	3 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperglycemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	174 Participants	183 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperglycemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	15 Participants	10 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperglycemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperglycemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	2 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperkalemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	194 Participants	194 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperkalemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	2 Participants	3 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperkalemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypermagnesemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	4 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypermagnesemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypermagnesemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	190 Participants	184 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypermagnesemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	2 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypermagnesemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypernatremia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	196 Participants	196 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypernatremia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypernatremia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypoalbuminemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	3 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypoalbuminemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypoalbuminemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	185 Participants	185 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypoalbuminemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	5 Participants	8 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypoalbuminemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypocalcemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	1 Participants	5 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypocalcemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	190 Participants	189 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypocalcemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	3 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypoglycemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	1 Participants	3 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypoglycemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	193 Participants	194 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypoglycemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypokalemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	155 Participants	159 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypokalemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	41 Participants	37 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypokalemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	2 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypomagnesemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	5 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypomagnesemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	190 Participants	187 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypomagnesemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	0 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyponatremia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	177 Participants	188 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyponatremia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	17 Participants	8 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyponatremia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	1 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyponatremia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypophosphatemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	3 Participants	3 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypophosphatemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypophosphatemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	153 Participants	153 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypophosphatemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade	33 Participants	33 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypophosphatemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	2 Participants
Intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypophosphatemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	3 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Chemistry laboratory test included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, chronic kidney disease, CPK increased, creatinine increased, GGT increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, and hypophosphatemia. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for chemistry laboratory test were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=160 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=160 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Alanine aminotransferase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Alanine aminotransferase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	152 Participants	154 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Alanine aminotransferase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	6 Participants	6 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Alanine aminotransferase increased: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Alkaline phosphatase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Alkaline phosphatase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	159 Participants	157 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Alkaline phosphatase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Aspartate aminotransferase increased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	3 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Aspartate aminotransferase increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	152 Participants	156 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Aspartate aminotransferase increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	4 Participants	4 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Blood bilirubin increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	157 Participants	159 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Blood bilirubin increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	3 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Chronic kidney disease: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Chronic kidney disease: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	130 Participants	134 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Chronic kidney disease: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	28 Participants	23 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Chronic kidney disease: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	2 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 CPK increased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	9 Participants	8 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 CPK increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	147 Participants	147 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 CPK increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	2 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Creatinine increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	153 Participants	155 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Creatinine increased: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	7 Participants	5 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 GGT increased: Missing (baseline grade) to Grade <=2 (CTCAE grade)	3 Participants	5 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 GGT increased: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	4 Participants	3 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 GGT increased: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	1 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypercalcemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	2 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypercalcemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	156 Participants	158 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperglycemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	4 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperglycemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	147 Participants	136 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperglycemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	8 Participants	14 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperglycemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	2 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperkalemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperkalemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	155 Participants	157 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperkalemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	2 Participants	3 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperkalemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyperkalemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypermagnesemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	4 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypermagnesemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	155 Participants	154 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypermagnesemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	2 Participants	2 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypernatremia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	158 Participants	159 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypernatremia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	2 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypoalbuminemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypoalbuminemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	151 Participants	157 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypoalbuminemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	6 Participants	3 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypocalcemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	2 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypocalcemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	154 Participants	155 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypocalcemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	3 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypocalcemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	0 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypoglycemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	4 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypoglycemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	155 Participants	156 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypoglycemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	3 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypokalemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypokalemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	129 Participants	139 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypokalemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	23 Participants	15 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypokalemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	1 Participants	2 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypokalemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	4 Participants	4 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypomagnesemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	2 Participants	4 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypomagnesemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	151 Participants	153 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypomagnesemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	6 Participants	2 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypomagnesemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyponatremia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	135 Participants	142 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyponatremia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade)	24 Participants	15 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyponatremia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hyponatremia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	2 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypophosphatemia: Missing (baseline grade) to Grade <=2 (CTCAE grade)	3 Participants	2 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypophosphatemia: Missing (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypophosphatemia: Grade <=2 (baseline grade) to Grade <=2 (CTCAE grade)	141 Participants	138 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypophosphatemia: Grade <=2 (baseline grade) to Grade 3/4 (CTCAE grade	12 Participants	17 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypophosphatemia: Grade 3/4 (baseline grade) to Grade <=2 (CTCAE grade)	0 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Chemistry Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Hypophosphatemia: Grade 3/4 (baseline grade) to Grade 3/4 (CTCAE grade)	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Coagulation laboratory test included: activated partial thromboplastin time prolonged, and INR increased. Laboratory results were categorically summarized according to the NCI-CTCAE criteria v4.03. Grade 0= no abnormality; Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Number of participants with shift from baseline for coagulation were assessed. Only those laboratory test parameters in which at least 1 participant had data were reported.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=6 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=11 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Activated partial thromboplastin time prolonged: Missing (baseline grade) to Grade 0 (CTCAE grade)	1 Participants	0 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Activated partial thromboplastin time prolonged: Missing (baseline grade) to Grade 1 (CTCAE grade)	0 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 0 (CTCAE grade)	0 Participants	4 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 1 (CTCAE grade)	1 Participants	2 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 2 (CTCAE grade)	0 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 3 (CTCAE grade)	1 Participants	0 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Activated partial thromboplastin time prolonged: Grade 1 (baseline grade) to Grade 1 (CTCAE grade)	1 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Missing (baseline grade) to Grade 0 (CTCAE grade)	1 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Missing (baseline grade) to Grade 1 (CTCAE grade)	0 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Missing (baseline grade) to Grade 2 (CTCAE grade)	1 Participants	0 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 0 (baseline grade) to Grade 0 (CTCAE grade)	0 Participants	2 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 0 (baseline grade) to Grade 1 (CTCAE grade)	1 Participants	0 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 0 (baseline grade) to Grade 2 (CTCAE grade)	1 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 0 (baseline grade) to Grade 3 (CTCAE grade)	0 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 1 (baseline grade) to Grade 0 (CTCAE grade)	0 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 1 (baseline grade) to Grade 1 (CTCAE grade)	0 Participants	3 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 1 (baseline grade) to Grade 2 (CTCAE grade)	1 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 1 (baseline grade) to Grade 3 (CTCAE grade)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=17 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=13 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Activated partial thromboplastin time prolonged: Missing (baseline grade) to Grade 0 (CTCAE grade)	1 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 0 (CTCAE grade)	8 Participants	5 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Activated partial thromboplastin time prolonged: Grade 0 (baseline grade) to Grade 1 (CTCAE grade)	5 Participants	7 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Activated partial thromboplastin time prolonged: Grade 1 (baseline grade) to Grade 0 (CTCAE grade)	1 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Activated partial thromboplastin time prolonged: Grade 1 (baseline grade) to Grade 1 (CTCAE grade)	1 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 Activated partial thromboplastin time prolonged: Grade 2 (baseline grade) to Grade 1 (CTCAE grade)	1 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Missing (baseline grade) to Grade 0 (CTCAE grade)	1 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 0 (baseline grade) to Grade 0 (CTCAE grade)	4 Participants	5 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 0 (baseline grade) to Grade 1 (CTCAE grade)	6 Participants	4 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 0 (baseline grade) to Grade 2 (CTCAE grade)	1 Participants	2 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 0 (baseline grade) to Grade 3 (CTCAE grade)	1 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 1 (baseline grade) to Grade 1 (CTCAE grade)	1 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 1 (baseline grade) to Grade 2 (CTCAE grade)	2 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Coagulation Laboratory Abnormalities Graded by NCI CTCAE v.4.03 INR increased: Grade 3 (baseline grade) to Grade 1 (CTCAE grade)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Induction, Day 10+/-1: pre-dose, 1, 4 hour (hr); Consolidation phase, Day 1: pre-dose, 1, 4 hr

Population: Analysis population included all participants who were treated and who had at least 1 value of analyte concentration of Glasdegib available. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "Number Analyzed" signifies participants evaluable for specific time points.

Ctrough of Glasdegib was measured in nanogram per milliliter (ng/mL).

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=123 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib Consolidation 1, Day 1	245.48 ng/ml Geometric Coefficient of Variation 80	—
Intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib Consolidation 2, Day 1	259.79 ng/ml Geometric Coefficient of Variation 122	—
Intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib Induction Day 10	413.54 ng/ml Geometric Coefficient of Variation 125	—

SECONDARY outcome

Timeframe: Pre-dose: Cycle 1 Day 15 and Cycle 2 Day 1

Ctrough of Glasdegib was measured in ng/mL.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=53 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib Cycle 1 Day 15	565.44 ng/ml Geometric Coefficient of Variation 126	—
Non-intensive Study: Plasma Trough Concentration (Ctrough) of Glasdegib Cycle 2 Day 1	472.42 ng/ml Geometric Coefficient of Variation 122	—

SECONDARY outcome

Timeframe: Day 1 up to maximum of 2 years

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of \<=450 to \>500 msec (post-baseline) were summarized. Number of participants with shift from baseline for QTc were assessed. Only those QTc parameters in which at least 1 participant had data were reported.

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=188 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=189 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: <=450 msec (baseline) to <=450 msec (post-baseline)	51 Participants	71 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: <=450 msec (baseline) to >450-<=480 msec (post-baseline)	64 Participants	63 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: <=450 msec (baseline) to >480-<=500 msec (post-baseline)	18 Participants	11 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: <=450 msec (baseline) to >500 msec (post-baseline)	11 Participants	6 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >450-<=480 msec (baseline) to <=450 msec (post-baseline)	2 Participants	3 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >450-<=480 msec (baseline) to >450-<=480 msec (post-baseline)	20 Participants	17 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >450-<=480 msec (baseline) to >480-<=500 msec (post-baseline)	16 Participants	10 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >450-<=480 msec (baseline) to >500 msec (post-baseline)	1 Participants	5 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >480-<=500 msec (baseline) to >450-<=480 msec (post-baseline)	1 Participants	0 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >480-<=500 msec (baseline) to >480-<=500 msec (post-baseline)	2 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >480-<=500 msec (baseline) to >500 msec (post-baseline)	1 Participants	0 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >500 msec (baseline) to >500 msec (post-baseline)	1 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: <=450 msec (baseline) to <=450 msec (post-baseline)	116 Participants	132 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: <=450 msec (baseline) to >450-<=480 msec (post-baseline)	50 Participants	39 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: <=450 msec (baseline) to >480-<=500 msec (post-baseline)	8 Participants	10 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: <=450 msec (baseline) to >500 msec (post-baseline)	5 Participants	0 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: >450-<=480 msec (baseline) to <=450 msec (post-baseline)	2 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: >450-<=480 msec (baseline) to >450-<=480 msec (post-baseline)	5 Participants	5 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: >450-<=480 msec (baseline) to >500 msec (post-baseline)	1 Participants	1 Participants
Intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: >480-<=500 msec (baseline) to >480-<=500 msec (post-baseline)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 up to maximum of 3 years

Outcome measures

Outcome measures
Measure	Intensive Study: Glasdegib + Cytarabine + Daunorubicin n=158 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gm/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CRMRD-negative central laboratory results, whichever came first (1.6 year).	Intensive Study: Placebo + Cytarabine + Daunorubicin n=155 Participants Participants received first induction therapy (28 days) (backbone chemotherapy+experimental therapy). Backbone chemotherapy: Cytarabine 100 mg/m\^2 daily by IV infusion for 7 days along with daunorubicin 60 mg/m\^2 daily IV for 3 days. Depending upon bone marrow blast or investigator judgement participants had second induction i.e. received either same backbone therapy or cytarabine 100 mg/m\^2 IV daily for 5 days and daunorubicin 60 mg/m\^2 IV daily for 2 days. Participants with \<5% bone marrow blasts entered into consolation phase- treated with either or both of following: 1) cytarabine 1 to 3 gram/m\^2 IV for adults \>=60 to \<60 years twice daily on Days 1, 3, and 5 for 4 cycle (each cycle 28 day) or cytarabine per local prescribing information. 2) Received HSCT per local standard of care. Experimental Therapy: Participants were to receive Glasdegib 100 mg matching placebo tablet PO QD from Day 1 of chemotherapy up to 28 days in both induction until 2 consecutive CR MRD-negative central laboratory results, whichever came first (1.8 year).
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: <=450 msec (baseline) to <=450 msec (post-baseline)	48 Participants	58 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: <=450 msec (baseline) to >450-<=480 msec (post-baseline)	53 Participants	43 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: <=450 msec (baseline) to >480-<=500 msec (post-baseline)	6 Participants	11 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: <=450 msec (baseline) to >500 msec (post-baseline)	7 Participants	3 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >450-<=480 msec (baseline) to <=450 msec (post-baseline)	0 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >450-<=480 msec (baseline) to >450-<=480 msec (post-baseline)	20 Participants	22 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >450-<=480 msec (baseline) to >480-<=500 msec (post-baseline)	13 Participants	8 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >450-<=480 msec (baseline) to >500 msec (post-baseline)	5 Participants	3 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >480-<=500 msec (baseline) to >450-<=480 msec (post-baseline)	1 Participants	2 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >480-<=500 msec (baseline) to >480-<=500 msec (post-baseline)	3 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcB: >480-<=500 msec (baseline) to >500 msec (post-baseline)	2 Participants	3 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: <=450 msec (baseline) to <=450 msec (post-baseline)	100 Participants	104 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: <=450 msec (baseline) to >450-<=480 msec (post-baseline)	39 Participants	36 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: <=450 msec (baseline) to >480-<=500 msec (post-baseline)	7 Participants	0 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: >450 - <=480 (baseline) to <=450msec (post-baseline)	1 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: >450 - <=480 msec (baseline) to >450 - <=480msec(post baseline)	0 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: >450 - <=480 msec (baseline) to >480 - <=500 msec (post baseline)	5 Participants	8 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: >480 msec (baseline) to <=500 msec (post baseline)	1 Participants	4 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: >450 - <=480 (baseline) to >500 msec (post baseline)	1 Participants	1 Participants
Non-intensive Study: Number of Participants With Shift From Baseline in Corrected QT (QTc) Interval QTcF: >480 - <=500msec (baseline) to >480 - <=500 msec (post baseline)	1 Participants	0 Participants

Adverse Events

Intensive Study: Glasdegib + Cytarabine + Daunorubicin

Serious events: 86 serious events

Other events: 194 other events

Deaths: 90 deaths

Intensive Study: Placebo + Cytarabine + Daunorubicin

Serious events: 92 serious events

Other events: 195 other events

Deaths: 88 deaths

Non-intensive Study: Glasdegib + Azacitidine

Serious events: 117 serious events

Other events: 154 other events

Deaths: 117 deaths

Non-intensive Study: Placebo + Azacitidine

Serious events: 124 serious events

Other events: 148 other events

Deaths: 113 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER