Trial Outcomes & Findings for Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) (NCT NCT02834390)

NCT ID: NCT02834390

Last Updated: 2025-03-05

Results Overview

Best response was defined as the best measured complete remission (CR), CR with incomplete hematological recovery (CRi), CR with incomplete platelet recovery (CRp), Partial remission (PR), or No response (NR) in the overall response assessments at all time points after the first dose. CR is defined as absence of leukemia cells morphologically; bone marrow blasts \<5 %; neutrophil count ≥ 1000 /mm 3; platelet count ≥ 100 ,000 /mm 3, independence of RBC transfusions for 4 weeks; independence of platelet transfusions for 1 week; absence of extramedullary leukemia.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 7 participants
• Primary outcome timeframe: Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year
• Results posted on: 2025-03-05

Participant Flow

A total of 7 participants who met all inclusion and no exclusion criteria were enrolled and received treatment in the study.

Participant milestones

Measure	Quizartinib 20 mg/Day Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.
Induction Phase STARTED	4	3
Induction Phase COMPLETED	2	1
Induction Phase NOT COMPLETED	2	2
Consolidation Phase STARTED	2	1
Consolidation Phase COMPLETED	1	0
Consolidation Phase NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Quizartinib 20 mg/Day Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.
Induction Phase Progressive disease	0	1
Induction Phase CR, CRp, or CRi not achieved (Induction Cycle 2)	2	0
Induction Phase Relapse after CR, CRp, or CRi	0	1
Consolidation Phase Physician Decision	1	1

Baseline Characteristics

Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Baseline characteristics by cohort

Measure	Quizartinib 20 mg/Day n=4 Participants Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day n=3 Participants Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	57.5 years STANDARD_DEVIATION 10.5 • n=5 Participants	53.7 years STANDARD_DEVIATION 17.1 • n=7 Participants	55.9 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Japan	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year

Population: Best response was assessed in the Efficacy Analysis Set.

Best response was defined as the best measured complete remission (CR), CR with incomplete hematological recovery (CRi), CR with incomplete platelet recovery (CRp), Partial remission (PR), or No response (NR) in the overall response assessments at all time points after the first dose. CR is defined as absence of leukemia cells morphologically; bone marrow blasts <5 %; neutrophil count ≥ 1000 /mm 3; platelet count ≥ 100 ,000 /mm 3, independence of RBC transfusions for 4 weeks; independence of platelet transfusions for 1 week; absence of extramedullary leukemia.

Outcome measures

Measure	Quizartinib 20 mg/Day n=4 Participants Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day n=3 Participants Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.
Summary of Best Responses After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Complete remission (CR)	0 Participants	0 Participants
Summary of Best Responses After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) CR with incomplete platelet recovery (CRp)	0 Participants	0 Participants
Summary of Best Responses After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) CR with incomplete hematological recovery (CRi)	3 Participants	2 Participants
Summary of Best Responses After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Partial remission (PR)	1 Participants	0 Participants
Summary of Best Responses After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) No response (NR)	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 0 to Day 21 of last completed cycle (each cycle 28 days), up to approximately 1 year

Population: Best response was assessed in the Efficacy Analysis Set.

Best response was defined as the best measured complete remission (CR), CR with incomplete hematological recovery (CRi), CR with incomplete platelet recovery (CRp), Partial remission (PR), or No response (NR) in the overall response assessments at all time points after the first dose.

Outcome measures

Measure	Quizartinib 20 mg/Day n=4 Participants Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day n=3 Participants Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.
Summary of Best Response Rates After the First Oral Dose of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Composite CR rate (CRc rate: CR+CRp+CRi)	75.0 percentage of participants Interval 30.1 to 95.4	66.7 percentage of participants Interval 20.8 to 93.9
Summary of Best Response Rates After the First Oral Dose of Quizartinib in Participants With Relapsed or Refractory Acute Myeloid Leukemia Response rate (CRc+PR)	100 percentage of participants Interval 51.0 to 100.0	66.7 percentage of participants Interval 20.8 to 93.9

PRIMARY outcome

Timeframe: Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days)

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

The maximum serum plasma concentration (Cmax) is reported at Induction phase Cycle 1, Day 9 and the maximum serum plasma concentration at steady state (Cmax,ss) is reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886.

Outcome measures

Measure	Quizartinib 20 mg/Day n=4 Participants Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day n=3 Participants Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of Geometric Means of Quizartinib and Active Metabolite (AC886) After Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia Cycle 1, Day 8: Quizartinib, Cmax	42.4 ng/mL Geometric Coefficient of Variation 25.7	91.3 ng/mL Geometric Coefficient of Variation 28.5
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of Geometric Means of Quizartinib and Active Metabolite (AC886) After Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia Cycle 1, Day 8: AC886, Cmax	36.5 ng/mL Geometric Coefficient of Variation 25.4	103 ng/mL Geometric Coefficient of Variation 37.0
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of Geometric Means of Quizartinib and Active Metabolite (AC886) After Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia Cycle 1, Day 8: Quizartinib + AC886, Cmax	77.4 ng/mL Geometric Coefficient of Variation 10.3	180 ng/mL Geometric Coefficient of Variation 16.0
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of Geometric Means of Quizartinib and Active Metabolite (AC886) After Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia Cycle 1, Day 21: Quizartinib, Cmax, ss	64.2 ng/mL Geometric Coefficient of Variation 64.0	212 ng/mL Geometric Coefficient of Variation 47.4
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of Geometric Means of Quizartinib and Active Metabolite (AC886) After Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia Cycle 1, Day 21: AC886, Cmax, ss	96.7 ng/mL Geometric Coefficient of Variation 23.7	256 ng/mL Geometric Coefficient of Variation 45.0
Pharmacokinetic Parameter Maximum Serum Concentration (Cmax) of Geometric Means of Quizartinib and Active Metabolite (AC886) After Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia Cycle 1, Day 21: Quizartinib + AC886, Cmax	162 ng/mL Geometric Coefficient of Variation 35.3	480 ng/mL Geometric Coefficient of Variation 2.4

PRIMARY outcome

Timeframe: Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days)

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

The area under the plasma concentration-time curve during dosing interval (AUCtau) of geometric means is reported at Induction phase Cycle 1, Day 9 and the area under the plasma concentration-time curve during dosing interval at steady state (AUCtauss) of geometric means are reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886.

Outcome measures

Measure	Quizartinib 20 mg/Day n=4 Participants Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day n=3 Participants Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.
Pharmacokinetic Parameter Area Under the Concentration-Time Curve During Dosing Interval of Quizartinib and Metabolite (AC886) After Daily Dose of 20 mg or 40 mg With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia Cycle 1, Day 21: AC886, AUCtau, ss	1940 ng*h/mL Geometric Coefficient of Variation 25.4	5310 ng*h/mL Geometric Coefficient of Variation 40.6
Pharmacokinetic Parameter Area Under the Concentration-Time Curve During Dosing Interval of Quizartinib and Metabolite (AC886) After Daily Dose of 20 mg or 40 mg With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia Cycle 1, Day 21: Quizartinib + AC886, AUCtau	3020 ng*h/mL Geometric Coefficient of Variation 42.3	8850 ng*h/mL Geometric Coefficient of Variation 0.3
Pharmacokinetic Parameter Area Under the Concentration-Time Curve During Dosing Interval of Quizartinib and Metabolite (AC886) After Daily Dose of 20 mg or 40 mg With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia Cycle 1, Day 8: Quizartinib, AUCtau	418 ng*h/mL Geometric Coefficient of Variation 50.4	921 ng*h/mL Geometric Coefficient of Variation 31.3
Pharmacokinetic Parameter Area Under the Concentration-Time Curve During Dosing Interval of Quizartinib and Metabolite (AC886) After Daily Dose of 20 mg or 40 mg With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia Cycle 1, Day 8: AC886, AUCtau	555 ng*h/mL Geometric Coefficient of Variation 28.8	1640 ng*h/mL Geometric Coefficient of Variation 24.4
Pharmacokinetic Parameter Area Under the Concentration-Time Curve During Dosing Interval of Quizartinib and Metabolite (AC886) After Daily Dose of 20 mg or 40 mg With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia Cycle 1, Day 8: Quizartinib + AC886, AUCtau	1010 ng*h/mL Geometric Coefficient of Variation 26.9	2640 ng*h/mL Geometric Coefficient of Variation 8.0
Pharmacokinetic Parameter Area Under the Concentration-Time Curve During Dosing Interval of Quizartinib and Metabolite (AC886) After Daily Dose of 20 mg or 40 mg With Chemotherapy to Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia Cycle 1, Day 21: Quizartinib, AUCtau,ss	991 ng*h/mL Geometric Coefficient of Variation 87.7	2940 ng*h/mL Geometric Coefficient of Variation 76.6

PRIMARY outcome

Timeframe: Induction phase Cycle 1, Day 8 to Cycle 1, Day 21 (each cycle 28 days)

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

The time of maximum plasma concentration (Tmax) of geometric means is reported at Induction phase Cycle 1, Day 9 and the time of maximum plasma concentration at steady state (Tmax,ss) of geometric means is reported at Induction phase Cycle 1, Day 21 for quizartinib, active metabolite AC886, and quizartinib and AC886.

Outcome measures

Measure	Quizartinib 20 mg/Day n=4 Participants Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day n=3 Participants Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.
Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 8: AC886, Tmax	5.01 hour Interval 2.05 to 6.03	6.08 hour Interval 4.03 to 6.17
Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 8: Quizartinib, Tmax	3.03 hour Interval 1.05 to 6.03	2.17 hour Interval 2.07 to 4.17
Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 8: Quizartinib + AC886, Tmax	4.01 hour Interval 2.05 to 6.03	4.17 hour Interval 4.03 to 6.17
Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 21: Quizartinib, Tmax,ss	4.03 hour Interval 2.03 to 4.13	4.08 hour Interval 4.05 to 4.12
Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 21: AC886, Tmax,ss	5.02 hour Interval 2.08 to 5.98	6.09 hour Interval 6.05 to 6.13
Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 21: Quizartinib + AC886, Tmax	4.03 hour Interval 2.08 to 5.93	4.08 hour Interval 4.05 to 4.12

PRIMARY outcome

Timeframe: Induction phase Cycle 1, Day 8 (each cycle 28 days)

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

The metabolite to parent ratio of geometric means for Cmax and AUCtau is reported at Induction phase Cycle 1, Day 9 for active metabolite AC886 is reported.

Outcome measures

Measure	Quizartinib 20 mg/Day n=4 Participants Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day n=3 Participants Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.
Pharmacokinetic Parameter Metabolite to Parent Ratio (MR) of Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 8: MR (Cmax)	0.861 metabolite to parent ratio Geometric Coefficient of Variation 43.8	1.13 metabolite to parent ratio Geometric Coefficient of Variation 45.6
Pharmacokinetic Parameter Metabolite to Parent Ratio (MR) of Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 8: MR (AUCtau)	1.33 metabolite to parent ratio Geometric Coefficient of Variation 64.1	1.78 metabolite to parent ratio Geometric Coefficient of Variation 56.4

PRIMARY outcome

Timeframe: Induction phase Cycle 1, Day 21 (each cycle 28 days)

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

The trough plasma concentration (Ctrough) of geometric means is reported at Induction phase Cycle 1, Day 21 for serum quizartinib, active metabolite AC886, and quizartinib and AC886.

Outcome measures

Measure	Quizartinib 20 mg/Day n=4 Participants Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day n=2 Participants Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.
Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 21: Quizartinib	22.7 ng/mL Geometric Coefficient of Variation 173.4	77.1 ng/mL Geometric Coefficient of Variation 117.6
Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 21: AC886	68.6 ng/mL Geometric Coefficient of Variation 49.3	195 ng/mL Geometric Coefficient of Variation 46.1
Pharmacokinetic Parameter Trough Plasma Concentration (Ctrough) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 21: Quizartinib + AC886	94.6 ng/mL Geometric Coefficient of Variation 68.5	299 ng/mL Geometric Coefficient of Variation 3.3

PRIMARY outcome

Timeframe: Induction phase Cycle 1, Day 21 (each cycle 28 days)

Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

The accumulation ratio of geometric means for Cmax and AUCtau is reported at Induction phase Cycle 1, Day 21 for serum quizartinib, active metabolite AC886, and quizartinib and AC886.

Outcome measures

Measure	Quizartinib 20 mg/Day n=4 Participants Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day n=2 Participants Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.
Pharmacokinetic Parameter Accumulation Ratio (AR) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 21: AC886 AR (Cmax)	2.65 accumulation ratio Geometric Coefficient of Variation 46.9	2.55 accumulation ratio Geometric Coefficient of Variation 7.2
Pharmacokinetic Parameter Accumulation Ratio (AR) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 21: Quizartinib + AC886 AR (Cmax)	2.09 accumulation ratio Geometric Coefficient of Variation 41.6	2.53 accumulation ratio Geometric Coefficient of Variation 16.2
Pharmacokinetic Parameter Accumulation Ratio (AR) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 21: Quizartinib AR (AUCtau)	2.37 accumulation ratio Geometric Coefficient of Variation 88.5	2.84 accumulation ratio Geometric Coefficient of Variation 36.2
Pharmacokinetic Parameter Accumulation Ratio (AR) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 21: Quizartinib AR (Cmax)	1.52 accumulation ratio Geometric Coefficient of Variation 72.1	1.98 accumulation ratio Geometric Coefficient of Variation 58.5
Pharmacokinetic Parameter Accumulation Ratio (AR) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 21: AC886 AR (AUCtau)	3.50 accumulation ratio Geometric Coefficient of Variation 56.2	3.31 accumulation ratio Geometric Coefficient of Variation 5.4
Pharmacokinetic Parameter Accumulation Ratio (AR) of Quizartinib and Active Metabolite (AC886) After a Daily Dose of 20 mg or 40 mg Combined With Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cycle 1, Day 21: Quizartinib + AC886 AR (AUCtau)	2.99 accumulation ratio Geometric Coefficient of Variation 59.5	3.24 accumulation ratio Geometric Coefficient of Variation 6.8

PRIMARY outcome

Timeframe: Induction phase Cycle 1, Day 1 up to 35 days after last dose in Cycle 2 (each cycle 28 days), up to approximately 1 year

Population: Adverse events were assessed in the Safety Analysis Set.

A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and coadministered drugs, or the start date of new AML post-treatment, whichever was earlier.

Outcome measures

Measure	Quizartinib 20 mg/Day n=4 Participants Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day n=3 Participants Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Pneumonia	1 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Skin infection	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Febrile neutropenia	4 Participants	3 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Anaemia	2 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Thrombocytopenia	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Immune Disorders	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Hypersensitivity	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Metabolism and Nutrition Disorders	3 Participants	2 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Decreased appetite	3 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Hypoalbuminaemia	1 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Hypokalaemia	2 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Hypomagnesaemia	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Hyponatraemia	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Hypouricaemia	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Tumour lysis syndrome	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Nervous System Disorders	2 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Dysgeusia	2 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Dizziness	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Eye Disorders	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Hypotension	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Respiratory, Thoracic, and Mediastinal Disorders	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Oropharyngeal pain	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Respiratory disorder	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Nausea	2 Participants	2 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Constipation	1 Participants	2 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Diarrhoea	1 Participants	2 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cheilitis	1 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Vomiting	1 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Pain in extremity	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Renal and Urinary Disorders	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Reproductive System and Breast Disorders	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Menorrhagia	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) General Disorders & Administration Site Conditions	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Oedema peripheral	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Pyrexia	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Investigations	4 Participants	3 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Gamma-glutamyltransferase increased	3 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Alanine aminotransferase increased	2 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Blood alkaline phosphatase increased	1 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Platelet count decreased	1 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Weight decreased	1 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) White blood cell count decreased	1 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Aspartate aminotransferase	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Aspartate aminotransferase increased	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Blood bilirubin increased	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Blood lactate dehydrogenase increased	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Blood pressure decreased	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Participants with TEAEs	4 Participants	3 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Infections and Infestations	1 Participants	3 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Staphylococcal bacteraemia	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Blood and Lymphatic System Disorders	4 Participants	3 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Leukopenia	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Hypophosphataemia	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Hepatic function abnormal	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Skin and Subcutaneous Tissue Disorders	4 Participants	3 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Alopecia	3 Participants	2 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Rash	1 Participants	2 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Rash maculo-papular	1 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Dermatitis bullous	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Dry skin	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Musculoskeletal and Connective Tissue Disorders	1 Participants	3 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Arthralgia	0 Participants	2 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Musculoskeletal pain	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Myalgia	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Haematuria	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Proteinuria	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Urinary tract pain	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Electrocardiogram QT prolonged	0 Participants	2 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Lipase increased	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Neutropenia	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Photophobia	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Cardiac Disorders	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Palpitations	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Vascular Disorders	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Epistaxis	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Gastrointestinal Disorders	3 Participants	3 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Abdominal pain upper	3 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Stomatitis	2 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Melaena	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Induction Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Hepatobiliary Disorders	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Consolidation phase Cycle 1, Day 1 up to 35 days after last dose (each cycle 28 days), up to approximately 1 year

Population: Adverse events were assessed in the Safety Analysis Set.

A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and coadministered drugs, or the start date of new AML post-treatment, whichever was earlier.

Outcome measures

Measure	Quizartinib 20 mg/Day n=2 Participants Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day n=1 Participants Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Participants with TEAEs	2 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Skin infection	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Blood and Lymphatic System Disorders	2 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Nervous System Disorders	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Dysgeusia	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Gastrointestinal Disorders	2 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Diarrhoea	2 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Nausea	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Stomatitis	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Skin and Subcutaneous Tissue Disorders	1 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Rash	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Rash maculo-papular	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) General Disorders & Administration Site Conditions	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Oedema peripheral	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Investigations	2 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) White blood cell count decreased	1 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Alanine aminotransferase increased	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Electrocardiogram QT prolonged	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Contusion	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Infections and Infestations	1 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Lung infection	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Upper respiratory tract infection	1 Participants	0 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Febrile neutropenia	2 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Platelet count decreased	1 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Injury, Poisoning, and Procedural Complications	0 Participants	1 Participants
Number of Participants Treatment-Emergent Adverse Events Reported During Consolidation Phase After a Daily Dose of 20 mg or 40 mg in Combination With Standard Chemotherapy to Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Fall	0 Participants	1 Participants

Adverse Events

Quizartinib 20 mg/Day

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Quizartinib 40 mg/Day

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Quizartinib 20 mg/Day n=4 participants at risk Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day n=3 participants at risk Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.
Infections and infestations Pneumonia	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.

Other adverse events

Measure	Quizartinib 20 mg/Day n=4 participants at risk Participants who received 20 mg quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.	Quizartinib 40 mg/Day n=3 participants at risk Participants who received 40 mg/day quizartinib once daily in the morning under fasting conditions. For the Induction phase, cytarabine (100 mg/m\^2/day IV) and either idarubicin (12 mg/m\^2/day IV infusion) or daunorubicin (60 mg/m\^2/day IV) were co-administered with quizartinib. For the Consolidation phase, cytarabine (3.0 g/m\^2/12 hours IV) was co-administered with quizartinib.
Infections and infestations Pneumonia	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Infections and infestations Skin infection	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Infections and infestations Lung infection	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Infections and infestations Upper respiratory tract infection	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Blood and lymphatic system disorders Febrile neutropenia	100.0% 4/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	100.0% 3/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Blood and lymphatic system disorders Anaemia	50.0% 2/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Blood and lymphatic system disorders Leukopenia	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Blood and lymphatic system disorders Neutropenia	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Blood and lymphatic system disorders Thrombocytopenia	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Immune system disorders Hypersensitivity	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Metabolism and nutrition disorders Decreased appetite	75.0% 3/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Metabolism and nutrition disorders Hypoalbuminaemia	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Metabolism and nutrition disorders Hypokalaemia	50.0% 2/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Metabolism and nutrition disorders Hypomagnesaemia	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Metabolism and nutrition disorders Hyponatraemia	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Metabolism and nutrition disorders Hypophosphataemia	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Metabolism and nutrition disorders Hypouricaemia	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Metabolism and nutrition disorders Tumour lysis syndrome	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Nervous system disorders Dysgeusia	75.0% 3/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Nervous system disorders Dizziness	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Eye disorders Photophobia	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Cardiac disorders Palpitations	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Vascular disorders Hypotension	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Gastrointestinal disorders Diarrhoea	75.0% 3/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	66.7% 2/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Gastrointestinal disorders Nausea	75.0% 3/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	66.7% 2/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Gastrointestinal disorders Abdominal pain upper	75.0% 3/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Gastrointestinal disorders Stomatitis	75.0% 3/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Gastrointestinal disorders Constipation	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	66.7% 2/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Gastrointestinal disorders Cheilitis	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Gastrointestinal disorders Melaena	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Skin and subcutaneous tissue disorders Alopecia	75.0% 3/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	66.7% 2/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Skin and subcutaneous tissue disorders Rash	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	66.7% 2/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Skin and subcutaneous tissue disorders Rash maculo-papular	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	66.7% 2/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Renal and urinary disorders Haematuria	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Renal and urinary disorders Proteinuria	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Renal and urinary disorders Urinary tract pain	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Reproductive system and breast disorders Menorrhagia	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
General disorders Oedema peripheral	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
General disorders Pyrexia	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Investigations Gamma-glutamyltransferase increased	75.0% 3/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Investigations Alanine aminotransferase increased	50.0% 2/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Investigations Electrocardiogram QT prolonged	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	100.0% 3/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Investigations Blood alkaline phosphatase increased	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Investigations Platelet count decreased	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Investigations Weight decreased	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Investigations White blood cell count decreased	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Investigations Aspartate aminotransferase	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Investigations Blood bilirubin increased	25.0% 1/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	0.00% 0/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Investigations Blood lactate dehydrogenase increased	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Investigations Blood pressure decreased	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Investigations Lipase increased	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Injury, poisoning and procedural complications Contusion	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.	33.3% 1/3 • Adverse events (AEs) were collected from Induction phase Cycle 1, Day 1 up to 35 days after last completed cycle in Consolidation phase, up to approximately 1 year. A treatment-emergent AE was defined as an AE that emerges (or worsens) from the first dose of study drug and coadministered drugs to the follow-up visit, 35 days after the last dose of study drug and co-administered drugs, or the start date of new acute myeloid leukemia post-treatment, whichever was earlier. The serious AEs (SAEs) reported occurred only in the Induction phase. No SAEs occurred during the consolidation phase. TEAEs at ≥5% are reported for both induction and consolidation phases.

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo, Inc.

Phone: 908-992-6400

Email: CTRinfo@dsi.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place